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Global J Res. Med. Plants & Indigen. Med. | Volume 2, Issue 1 | January 2013 | 52–64

Global Journal of Research on Medicinal Plants & Indigenous Medicine || GJRMI ||

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A COMPARATIVE CLINICAL EVALUATION OF THYROMAX POWDER

AGAINST THYROXINE SODIUM IN THE MANAGEMENT OF

HYPOTHYROIDISM

Ujjaliya Nitin1*, Krishnankutty S V

2, Remadevi R

3

1Assistant Prof., Dept. of Dravyaguna Vijnana, Shri Dhanwantry Ayurvedic College & Dabur Dhanwantry

Hospital, Chandigarh, India 2Head, Department of Internal medicine, Maulana Hospital, Perinthalmanna, Kerala, India

3Prof. & Head, Dept. of Dravyaguna Vijnana, V.P.S.V. Ayurveda College, Kottakkal, Kerala, India

*Corresponding Author: Email: [email protected]

Received: 06/12/2012; Revised: 01/01/2013; Accepted: 07/01/2013

ABSTRACT

The thyroid gland regulates metabolism of the body by virtue of its hormones. Insufficient levels

of thyroid hormone causes signs and symptoms such as slower metabolic rate, weight gain,

sleepiness, dry and cool skin, as well as others. This condition collectively can be called as

Hypothyroidism. Of the different types, Primary Hypothyroidism is the commonest which occurs

after destruction of thyroid follicles mainly because of autoimmunity. Hypothyroidism is most

common in women than men. According to a study, it affects 3.9% people with 9.4% subclinical

condition. The sole available treatment for this in conventional science is Hormone Replacement

Therapy which is not always free from side effects and has to be taken lifelong. This study was

aimed to search an option for Hypothyroidism in terms of herbs. Traditionally practiced drugs

Guducī Satvam (Tinospora cordifolia Miers.) and Āmalakī cūrnam (Phyllanthus emblica Linn.) was

taken in a combination named „Thyromax powder’ which was standardized before commencing with

clinical trial. A controlled clinical trial was planned with 20 newly diagnosed participants, which

were not exposed to any medicament, with Thyroxine sodium in control group and Thyromax

powder in study group for the duration of 3 month. Assessment was done on the basis of six

subjective parameters and thyroid function test. Statistically, study drug showed a positive

correlation on subjective parameters while control group showed significant result on T3 and T4

levels. Both the groups were found statistically insignificant on TSH level.

KEY WORDS: Thyromax powder, Hypothyroidism, Standardization, controlled clinical trial.

Research article

Cite this article:

Ujjaliya Nitin, Krishnankutty S V, Remadevi R (2013), A COMPARATIVE CLINICAL EVALUATION

OF THYROMAX POWDER AGAINST THYROXINE SODIUM IN THE MANAGEMENT OF

HYPOTHYROIDISM, Global J Res. Med. Plants & Indigen. Med., Volume 2(1): 52–64

mailto:[email protected]



INTRODUCTION

Endocrinology concerns the synthesis,

secretion and action of hormones. Hormones

are chemical messengers which have diverse

molecular structures and are related to

endocrine glands thereby coordinate the

activities of different cells. Some endocrine

disorders are common, particularly those of the

thyroid gland. At present thyroid diseases form

the second most common endocrine disorder in

India next to Diabetes mellitus. (Sir Stanley

Davidson, Davidson Principles & Practice of

Medicine; 2006). According to the report of N.

Kochupilli, thyroid disorders (5.4%) are the

most common among all the endocrine diseases

in India (N. Kochupillai et al., 1986).

Unfortunately many people may have this

disease and even not realize it. According to a

study known as a “Colorado thyroid disease

prevalence study” there may be as 13 million

Americans with an undiagnosed thyroid

condition (Gay J Canaris et al., 2000). In the

state of Kerala, India, 9.4% people who suffer

from hypothyroidism are asymptomatic

(Unnikrishnan AG et al., 2011). Wickham

Survey suggested that there is a high possibility

of developing Hypothyroidism in the

population with raised TSH and thyroid

antibodies. In the after follow up study it was

demonstrated to be much accurate. It was

inferred that increasing values of serum TSH

above 2mU/l increases the probability of

developing hypothyroidism which was further

increased in the presence of anti-thyroid

antibodies (Vanderpump MP, 1995). According

to a study anti-thyroid antibodies were found in

89.6% of the women between 15–35 years of

age and the overall prevalence of classical

Hypothyroidism was found to be 10 times more

than the men (K.P. Paulose, 2011). This made

the medical society to consider it with a higher

importance, as it may result in severe

complications. The possibility of incidence of

the disease also increases with a higher rate in

old age.

In Hypothyroidism, body function

decreases and this leads to a slow heart rate, an

increase in cholesterol level, mild anemia,

pervasive fatigue, depression, low body

temperature, cold intolerance, coarsening of

skin, muscles and joint aches, constipation,

weight gain, slow hair growth, loss of libido,

infertility, increased risk of miscarriage and

irregular menstrual cycle in women etc. In the

most common case of Hypothyroidism, namely

Primary Hypothyroidism resulting from an

intrinsic disorder of thyroid gland, serum T3

and T4 is low and TSH elevated also called as

classical Hypothyroidism, resulting above signs

and symptoms. (Sir Stanley Davidson,

Davidson Principles & Practice of Medicine;

2006).

According to the signs and symptoms, it is

concluded that Hypothyroidism is a resultant of

Vāta-kapha-medo vikrti and

Dhātvāgnimāndhya (Alsa mariyam

kalathancheri, 2008 and Chanchal Gupta,

2003). Guducī and Āmalakī are known for

Rasāyana property and have action on

Dhātvāgni specially Rasa and Rakta. Both the

drugs have been proven as immunomodulators

and anti-oxidant effects. (Dikshit V et al., 2003

and Shukla V et al., 2009). Prevalence of

autoimmune Hypothyroidism is much higher

(K.P. Paulose, 2001). Considering rejuvenative

effect of these herbs, they may rejuvenate

destroyed follicles of thyroid gland which are

responsible for production of thyroid

hormones; of course it is questionable and

needs further research. These are proved drugs

for many diseases and found non toxic. These

two drugs are not found to have any drug

interactions. (Database on Medicinal Plants

used in Ayurveda, 2005). Guducī Satvam

(extract of Tinospora cordifolia Miers.) along

with Āmalakī cūrnam (powder of fruit of

Phyllanthus emblica Linn.) is used by the

traditional vaidyas for Hypothyroidism in

Madhya Pradesh and found effective.

In modern medicine hormone supplement is

the only management for this disease. Though

it is thought to be a successful therapy but a

long term hormone therapy is not always free

from complications as well as side effects.

Most often it is needed to continue throughout

the life in adjusted doses.



This study was an effort to evaluate the

effect of these two drugs in a combination

which is named as “Thyromax powder” on the

clinical symptoms and T3, T4 and TSH levels

of Hypothyroidism.

MATERIALS AND METHOD

Study design

The study design was a controlled clinical

trial. Randomization was not done due to two

different settings. Newly diagnosed participants

were selected as per the inclusion and exclusion

criteria. The control selected here was not a

concurrent control. The control group was

selected from an accessible population at

Maulana Hospital, Perinthalmanna, Kerala,

India. A detailed clinical examination was done

before and after the study using a prepared case

record form. Analysis of both the treatments

was done by evaluating subjective and

objective parameters.

Sample collection and preparation of study

drug

The fresh Stem of Tinospora cordifolia

were collected from nearby areas of Kottakkal,

Kerala, India. The stem cuttings were properly

identified in the department using external

morphological and histological characters.

Satvam was prepared as per the procedure

given in the text. (Yogaratnākara Rājayaksamā

Cikitsā; 328, Verse no. 1-11/2)

The fresh fruit of Phyllanthus emblica of

similar size were bought from market. The

fruits were identified in the department and

well dried in shade. Powder was prepared in the

size of 40–80 microns. (The Ayurvedic

Pharmacopoeia of India, 2001)

Physicochemical Standardization of

Thyromax powder

In the present study the combination of

Satvam of Tinospora cordifolia and fine

powder of dried fruits of Phyllanthus emblica

in the ratio of 1:3; given the name Thyromax

powder were subjected to preliminary

physicochemical screening for the

standardization of drug and extraction of plant

constituents.

(Quality Standards of Indian

medicinal Plants, and The Ayurvedic

Pharmacopoeia of India, 2001). (Table no. 2 -

4)

Phytochemical analysis

Quantification of characteristic compounds

The extracts obtained were subjected to

qualitative tests for the identification of various

plant constituents. (Quality Standards of Indian

medicinal Plants, 2003 and The Ayurvedic

Pharmacopoeia of India, 2001). (Table no. 5 -

7)

Thin Layer Chromatography & HPTLC

Selection of chromatographic layer

Pre-coated TLC silica gel 60 F254 (E.

Merck) plates on aluminum sheet were used for

chromatographic profile for individual drugs

and for Thyromax powder. TLC of all

successive solvent extractives of Thyromax

powder was prepared. While HPTLC

fingerprinting of methanolic extract of Guducī

Satvam, Āmalakī cūrnam and Thyromax

powder was prepared.

Selection of mobile phase for TLC

a] For Thyromax powder

Before the application of the samples to the

plates, an appropriate solvent system was

selected. The solvent system was chosen by the

trial and error method. The solvent systems

used for the TLC analysis were different for

different successive solvent extractives.

For Petroleum ether extract – n-hexane :

ethyl acetate : formic acid (10:2:0.2)

For Cyclohexane extractive – Toluene :

ethyl acetate : formic acid (8:2:0.2 )

For Acetone & Ethanol extract –

Toluene : ethyl acetate : formic acid

(5:5:1)

Selection of mobile phase for HPTLC

a] For Guducī Satvam

For methanolic extract – toluene : ethyl

acetate : formic acid (7:5:1)



b] For Āmalakī cūrnam



c] For Thyromax powder



Application of sample

For the application of sample CAMAG

Automatic TLC sampler IV were used and the

concentration of sample extractives were

between 0.2 to 0.6 micro liters.

Pre-conditioning

Saturated chamber by lining with filter

paper for 30 minutes was prepared prior to

development for getting better Rf values. For

this CAMAG ADC-2 Automatic development

chamber was used.

Chromatographic development and drying

After development, the plates were taken

out and mobile phase was completely removed

from the plate by drying in vacuum desiccators.

Detection and visualization

Detection under UV light is the first choice

so plates were visualized in CAMAG TLC

Visualizer and photographs were taken in UV

254 and 365 nm. wavelength. Since very dim

spots were obtained in visible light, the TLC

plates were then sprayed with Anasaldehyde

sulphuric acid and dried in hot air oven at

110oC. The colors of the spots were recorded

and their positions were marked. The distance

travelled by each band was measured and

respective Rf values were calculated.

TLC analysis of Thyromax powder

For TLC study of Thyromax powder,

Petroleum ether, Cyclohexane, Acetone and

Ethanol extractives were spotted in the solvent

system given in the literature of TLC under

heading selection of solvent system. Eluents

were different for all extractives (common for

Acetone and Ethanol) hence Rf values, TLC

photographs are given separate.

HPTLC analysis

HPTLC profile was prepared for Guducī

Satvam, Āmalakī cūrnam and for the

combination Thyromax powder separately. The

mobile phase and extracts were different for

samples and has been mentioned earlier. For

Methanolic extract of Guducī Satvam and

Āmalakī cūrnam table of Rf value, TLC plate

photos and HPTLC over view and area graphs

are given separately.

Clinical study

In the present study randomization was not

done hence comparison of demographic details

and base line values of both the groups were

done. Comparison of response to the treatment

within both the groups was done. Total 20

participants were registered for the present

study, each 10 in study and control group. All

participants received full course of treatment

and completed their course successfully

without any interruption, hence there were no

dropouts in the study.

Data outcome were tabulated; mean

deviation, standard deviation and percentage

between the assessments were calculated.

Student „t‟ test was applied to find out level of

significance for all the parameters with in the

treatment and control group. The data were

statistically analyzed before and after

intervention.

RESULTS

Organoleptic characters

Detailed in (Table 1)

Powder microscopy Guducī satvam

Starch grains of Guducī showed deep blue

color when mounted with Iodine solution.

Every particle of Satvam was separated from

each other. The shapes of Satvam particle was

not similar and varies in size from other

particles. Starch grains of Guducī were

approximately 5.5–11.20µ in diameter and 6–

11.28µ in length. (Fig. no. 1&2).



Powder microscopy of Āmalakī cūrnam

Powder showed hexagonal, thick, straight-

walled epidermal cells in surface view

embedded with small prismatic crystals of

silica; isolated or groups of thin-walled pitted

stone cells; fragments of thick walled fibers and

sclereids; fragments of pitted vessels, tracheids

and parenchyma, crystals of silica and simple

oval to spherical starch grains scattered as such

or embedded in the parenchymatous cells of the

mesocarp. (Fig.no.3-6) (The Ayurvedic

Pharmacopoeia of India).

Table 1. Organoleptic Characters

No. Characters Characteristics of Satvam Characteristics of Āmalakī cūrnam

1 Touch Fine and Smooth Rough

2 Color White Light grey

3 Taste Sweet Bitter, Sour and Sweet astringent

4 Odor Odorless Odorless

5 Consistency Fine powder Fine powder

Fig. 1–2 Powder Microscopy of Guducī Satvam

Fig. 3–6 Powder Microscopy of Āmalakī Cūrnam

Table 2. Physicochemical standards of Thyromax powder

Sr. No. Experiments Percentage

1. Total ash 3.05%

2. Water insoluble ash 2.23%

3. Acid insoluble ash 1.47%

4. Moisture content 11%

5. Volatile oil content 01%

6. Sugar content

a. Total Sugar 13.1%

b. Reducing sugar 7.23%

7. Fibre content 3.0%



Table 3. Percentage of water soluble and alcohol soluble extractives

No. Name of extract Percentage of extract Color / Consistency

1. Hot water soluble 80.75% Blackish brown / Dry

2. Cold alcohol soluble 27.40% Dark brown / Oily

3. Hot alcohol soluble 50.00% Dark brown / Oily

Table 4. Successive solvent extractives

No. Experiments Percentage Color /Consistency

1. Petroleum ether 1.63 % Light yellow / Oily

2. Cyclohexane 0.80 % Lemon yellow/Oily

3. Acetone 12.0 % Dark brown / Oily

4. Ethanol 11.0 % Dark brown / Oily

Table 5. Qualitative Phytochemical analysis of the extractives

Solvent Steroid Alkaloids by Phenol Flavonoids Tannins

Mayer’s DDR

Petroleum ether + – + – – +

Cyclohexane – + + – – +

Acetone + – + + + +

Ethanol + – + + + +

Water + – – + + +

Cold alcohol + – + + + +

Hot alcohol + – + + + +

Table 6. Rf values of different spots of Thyromax powder

Petroleum ether

extract

Cyclohexane

extract

Acetone extract Ethanol extract

7 Spots 5 Spots 3 Spots 7 Spots

Colour of

Spot Rf Colour

of Spot

Rf Colour of

Spot

Rf Colour of Spot Rf

Violet 0.24 Purple 0.40 Brown 0.12 Pale brown 0.07

Violet 0.31 Purple 0.48 Brown 0.34 Pale brown 0.13

Violet 0.36 Purple 0.66 Light

violet

0.46 Pale brown 0.17

Violet 0.40 Violet 0.78 - - Pale brown 0.24

Pale pink 0.61 Violet 0.88 - - Brown 0.35

Violet 0.68 - - - - Light green 0.41

Pale

Violet

0.80 - - - - Light violet 0.49



TLC of Thyromax powder (Fig. no. 7-18)

Fig. no. 7- 9: TLC plate of Petroleum ether extract of Thyromax powder

Fig. no. 10- 12: TLC plate of Cyclohexane extract of Thyromax powder

7: 254 nm 8: Derivatized plate. 9: 366 nm. 10: 254 nm. 11: Derivatized plate. 12: 366 nm.

Fig. no. 13- 15: TLC plates of Acetone extract of Thyromax powder

Fig. no. 16- 18: TLC plates of Ethanolic extracts of Thyromax powder

13: 254 nm 14: Derivatized plate. 15: 366 nm. 16: 254 nm. 17: Derivatized plate. 18: 366 nm.

Table 7. Rf value details of Methanolic extract of Guducī Satvam, Āmalakī cūrnam and

Thyromax powder.

Guducī Satvam Āmalakī cūrnam Thyromax powder

Spots Spots Spots

Color Rf Color Rf Color Rf

Light orange 0.80 Blue 0.18 Dark blue 0.18

Light orange 0.40 Blue 0.60

Light violet 0.70 Pink 0.70

Pink 0.80



TLC of Āmalakī curnam and Guducī satvam (Fig. no. 19-23)

Fig. no. 19- 21: TLC plates of Methanolic extract

Fig. no. 22- 23: TLC plates of Methanolic extract of Thyromax powder.

19: Āmalakī at 254nm 20: Āmalakī at 366nm 21: Guducī at 366nm. 22: 254 nm 23: 366nm

HPTLC Over view graphs of study drugs (Fig. no. 24-31)

Fig. no. 24: Over view graph of Methanolic extract of Āmalakī at 254nm

Fig. no. 25: Area graph of Methanolic extract of Āmalakī at 254 nm.

Fig. no. 26: Over view graph of Methanolic extract of Guducī Satvam at 254 nm

Fig. no. 27: Area graph of Methanolic extract of Guducī Satvam at 254 nm



Fig. no. 28: Over view graph of Methanolic extract of Thyromax powder at 254 nm

Fig. no. 29: Area graph of Methanolic extract of Thyromax powder at 254 nm

Fig. no. 30: Over view graph of Methanolic extract of Thyromax powder at 366 nm

Fig. no. 31: Area graph of Methanolic extract of Thyromax powder at 366 nm

Data related to response to the treatment

Graph 1. Effect of the treatment on weight gain Graph 2. Effect of the treatment on excessive sleep

00.20.40.60.8

11.21.4

BT AT

1.2

0.3

1.3 1.2

Effect of the treatment on weight

gain

Study

Control

0

0.5

1

1.5

2

2.5

BT AT

2.2

0.2

1.91.6

Effect of the treatment on

excessive sleep

Study

Control



Graph 3. Effect of the treatment on muscle cramp Graph 4. Effect of the treatment on edema

Graph 5. Effect of the treatment on dry skin Graph 6. Effect of the treatment on constipation

Graph 7. Effect of the treatment on T3 parameter Graph 8. Effect of the treatment on T4 parameter

0

1

2

3

BT AT

2.2

0.2

2.0 1.7

Effect of the treatment on muscle

cramp

Study

Control

0

0.5

1

1.5

2

BT AT

1.8

0.4

1.31.1


edema

Study

Control

00.20.40.60.8

11.21.41.61.8

2

BT AT

2.0

0.6

1.5 1.4

Effect of the treatment on dry

skin

Study

Control

0

0.5

1

1.5

2

2.5

3

BT AT

2.8

0.0

2.4

2.1


constipation

Study

Control

0

0.2

0.4

0.6

0.8

1

BT AT

0.696 0.7190.658

0.822

Effect of the treatment on T3 parameter

Study

Control

0

10

20

30

40

50

60

70

BT AT

54.01 54.91

43.76

65.92

Effect of the treatment on T4 parameter

Study

Control



Graph 9. Effect of the treatment on TSH

DISCUSSION

Pharmacognostical study

Moisture content of the shade dried drug

determined by Dean & Starks apparatus was

found to be 11%. Total ash of any drug is the

residue obtained on its complete incineration in

an electric Bunsen burner. This mainly

represents the inorganic salts present in the

drug, if the drug is pure and any impurities like

sand, soil etc. adhering to the drug will also

remain as ash, thus increasing the ash value

several fold. Ash value is the general criterion

to ascertain the purity of the drug. Total ash

value of the drug was found to be 3.05%. Water

insoluble ash mainly gives the percentage of

organic matter present in the ash and this was

found to be 2.23%. Acid insoluble ash, which

mainly gives the percentage of the sand and

impurities that remain insoluble in HCl and it

was found to be 1.47%. Water soluble extracts

of the drug mainly represents the percentage of

organic constituents such as tannins, sugars,

plant acids, mucilage and glycosides. Alcohol

soluble extracts mainly represents the

percentage of organic constituents such as

alkaloids, phenols, flavanoids, steroids, sugars

etc. present in the drug.

Successive solvent extraction, which is the

extraction of the drug with organic solvents of

increasing polarity, was applied for the

isolation of active constituents from the crude

drug. The highest percentage of extract was

obtained by the extraction with acetone (12.0

%) and least with the solvent cyclo-hexane 0.80

percent.

The extracts obtained by exhausting crude

drugs are indicative of approximate measure of

their chemical constituents. Successive

extraction showed scattered results because of

the combination of two drugs. Due to Āmalakī

cūrnam (Phyllanthus emblica) tannin present in

all the extracts and steroids are present in all

except cyclohexane extractive. While alkaloid

(by Mayer‟s reagent) is present only in

cyclohexane extract and alkaloid by

Dragendroff‟s reagent present in all except

water soluble extract. Phenol and flavonoids

are present in all the extract except petroleum

ether and cyclohexane extractives.

Clinical study

Student „t‟ test was applied to find out level

of significance for all the parameters with in

the treatment and control group. The data were

statistically analyzed before and after

intervention. Both the groups were not

compared since only study group showed

significant improvement on subjective

parameters and only control group showed

0

10

20

30

40

50

60

70

BT AT

55.99

23.46

62.79

8.17

Effect of the treatment on TSH

Study

Control



significant improvement on T3 and T4 level.

None of them showed significant effect on TSH

parameter.

Probable Mode of Action in a nut shell

It has been established for a very long time

that there is a complex relationship between

thyroid disease, body weight and metabolism.

(K.P. Paulose, 2011). Thyroid hormones

regulate metabolism in human. It is also

reported that difference in BMRs are associated

with changes in energy balance. (K.P. Paulose,

2011). Studies concluded that under secretion

of thyroid hormones leads to low BMR and

thereby weight gain, decrease in energy balance

causes sleepiness and muscle cramps. Once the

drug holds the body metabolism all these

symptoms get relieved. Functions of thyroid

hormone have a close resemblance to the

Dhātvāgni (digestive potency of cells). (Alsa

mariyam kalathancheri, 2008). Constipation is

the foremost symptom of this disease which

may be due to Agnimāndhya (loss of appetite)

and Āma (indigested food material). Both the

drugs are considered most excellent Pitta

śamakas (drugs which mollify Pitta) and hence

balance the Pitta and regularize the Dhātvāgni.

Madhura (sweet) and Amlarasa (sore), Snigdha

guna, Madhura Vipāka and Usna Vīrya

(warmth in potency) of drugs simply mollify

the aggravated Vāta. Kasāya rasa, Ruksa guna

and Usna Vīrya eliminate the kapha in channels

and also help in improving Agni. Once Agni get

normalized, the signs and symptoms of

Hypothyroidism like constipation, weight gain,

excessive sleep and muscle cramp all get

relieved. Guducī Satvam having Snigdha guna

and Madhura rasa reduces the dryness of skin.

Āmalakī cūrnam by virtue of its Ruksa guna

reduces the excess accumulated water in case

of Hypothyroidism which is the main cause of

weight gain.

Study drugs, Guducī Satvam and Āmalakī

cūrnam both having Rasāyana properties are

best for longstanding disease like

Hypothyroidism. In case of primary

Hypothyroidism, the anomaly happens is in

thyroid gland itself. The under-production of

thyroid hormones leads to increased TSH from

pituitary and various signs and symptoms.

Considering rejuvenative property of drugs,

their outcome can be justified. Being pitta

śamana, they reduce inflammatory changes;

being vāta śamana (drugs which mollify vāta)

may reverse the condition of destroyed thyroid

follicles or hold up the follicles to amplify the

liberation of hormones. Anti-oxidant and

immuno-modulatory effect of these drugs helps

in this action.

CONCLUSION

HPTLC finger print showed more than four

chemical constituents present in Guducī

Satvam. HPTLC finger print showed 11 peaks

may represent chemical constituents present in

Āmalakī cūrnam. There is no negative

impression in HPTLC profile of Thyromax

powder due to combination of two herbs.

Thyromax powder is found to be more effective

in reducing the subjective parameters.

Thyroxine sodium is found to be more effective

on T3 and T4 parameters. Thyromax powder

and Thyroxine sodium both are found to be

insignificant on TSH level parameter.

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