Ph.D.Research Proforma

Page xii

Department of Panchakarma

Speciality – Manovigyan avum Manas Roga

Institute of Post Graduate Teaching & Research in Ayurveda

Gujarat Ayurved University Jamnagar

Ph.D. RESEARCH PROFORMA

Title: A study on Vishada w.s.r to Generalized Anxiety Disorder and its management

with Ashwagandha - a randomised double blind clinical study

Scholar: Dr.Khyati Santwani

Guide: Dr.Anup.B.Thakar

Coguide: Dr.Arun.Khatri

Year: 2009-2011

Patient’s name: Sr.No:

Sex: Male/Female Date:

Age: Group:

Address: Ward/Bed. No:

O.P.D.No:

Religion: H/M/C/J/O I.P.D.No:

Occupation: Housewife/Labour class/Service/Unemployed/Business/

Retired/Student/Other

Education: UE/PE/SE/HS/G/PG Date of commencement:

Family: Nuclear/Joint Date of completion:

Marital status:M/UM/W/Divorcee

Socio-economic status: P/LM/M/UM/R Diagnosis:

Habitat: Urban/Suburban/Rural Result:

Source of history- Patient / Informant with relation to the patient-

Ph.D.Research Proforma

Page xiii

Chief Complains:

Symptoms Present Duration

Excessive Anxiety

Unwanted worry

Restlessness

Easy fatigue

Difficulty in concentration

Irritability

Muscle tension

Sleep disturbances

History of past illness:

Psychiatric illness:

Medical illness:

Alcohol and other substance history:

Drug history:

Precipitating life events:

Progress of illness:

Family history:

a) Pedigree chart:

b) Psychiatric history in family: Present/Absent

c) Drug addiction: Present/Absent

d) History of suicide: Present/Absent

Ph.D.Research Proforma

Page xiv

e) General atmosphere within family: Satisfactory/Unsatisfactory

f) Other family problems: Present/Absent

g) Current relationship with family members: Satisfactory/Unsatisfactory

BIRTH & CHILDHOOD HISTORY:

FTND: Yes/No

Developmental milestones: Proper/Delayed

Childhood habits: Bed wetting/Nail biting/Thumb sucking/Mannerisms/Fear of

darkness/Night mares/Somnambulism

Childhood personality:

Shy/Restless/Hyperactive/Introvert/Extrovert/Timid/Friendly/Playing alone

Conduct in school: Satisfactory/Unsatisfactory

Scholastic performance: Satisfactory/Unsatisfactory

History of separation anxiety: Present/Absent

Childhood illness:

ADULTHOOD HISTORY:

Occupational history:

Feeling about current job: Satisfied/Unsatisfied

Relationship with co-workers: Satisfactory/Unsatisfactory

Marital history:

Marital life: Satisfactory/Unsatisfactory

Duration of marriage

Sexual life: Satisfactory/Unsatisfactory

Extramarital affairs: Present/Absent

Psychosocial history:

Mood:Normal/Elevated/Depressed/Anxious/Irritable/Anger/Tension/Fear/Jealous

Friends:Yes/No/Less/More

Relations: No/Less/Long lasting/Time being

Home life: Happy/Unhappy/Not bad/Misunderstanding

Housing: Satisfactory/Unsatisfactory

Financial problems: Yes/No

Ph.D.Research Proforma

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Menstrual history: (Applicable only for female patients)

Regular/Irregular

Menarche:

Emotional disturbances related to menstrual cycle: Present/Absent

Amenorrhea/Dysmenorrhea/Menopause/Others

Obstetric history:

Nature of delivery: Normal/Cs/Forceps/Premature/Others

G P A L D

(Gravida, Parity, Abortion, Live birth, Dead birth)

Sex of Child: Male/Female

Health status of Child: Healthy/Disease

Personal history:

1) Diet: Veg/Mixed

2) Dietary habits: Samashana/Vishamashana/Adhyashana/Virrudhashana

3) Appetite: Poor/Moderate/Good/Very good

4) Agni: S/V/M/T

5) Kostha: Krura/Mridu/Madhyam

6) Food: Satvika/Rajasika/Tamasika dominant

7) Bowel: Regular/Irregular/Constipated/Loose motion

8) Micturation:

9) Nature of sleep: Sound/Disturbed

10) Dreams: Yes/No

Nature of dreams:

11) Addiction: Tea/Coffee/Smoking/Tobacco/Alcohol/Pan/Drug/Other

Frequency-

Quantity-

Dashavidha Pariksha:

Prakriti: Sharira: VP/VK/PK/VPK

Manasa: S/R/T

Ph.D.Research Proforma

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Vikriti:Sharirika/Manasika/Manodaihika

Sara: Pravara/Madhyama/Avara

Samhanana: Pravara/Madhyama/Avara

Pramana: Pravara/Madhyama/Avara Height: Weight:

Satmya: Pravara/Madhyama/Avara

Satva: Pravara/Madhyama/Avara

Ahara Shakti: Abhyavarana Shakti: Pravara/Madhyama/Avara

Jarana Shakti: Pravara/Madhyama/Avara

Vyayama shakti: Pravara/Madhyama/Avara

Vaya: Bala/Yuva/Vriddha

Vital Data: B.T. A.T.

Pulse:

B.P. :

Temp.:

Resp.:

Vikriti Pariksha:

Dosha Pariksha:

Vata Dosha:

Vriddhi Kshaya Prakopa

Darshana Kaarshya/

Krishnata/

Gaadha

Varchastwam

/Anaaha

Alpa Chestataa/Alpa

Vaaktwam/Mudha

Sangnataa/Uchchhw

-aasa Nishwaasa

Mandataa

Khanja/Pangu/Kubjatwa/

Angashosha/Aakshepa

Sparshana Twak Parushya Gatra suptata

Prashna Vaakparushya/

Gaatrasphurana/

Ushna Kaamitaa/

Nidranaasha/Sakti

graha/Indriya

bhransha/Dainya/

Apraharsha/Utsaaha

hani/Sweda-Mutra-

Purisha Manda

pravritti

Sankocha/Parvastambha/

Asthibheda/Parvabheda/

Anidrataa/Garbha-Shukra-Raja

naasha/Sira spandana/Naasa-

Akshi-Jatru-Grivaa

Bheda/Toda/Arati/Moha/Aayasa/

Ph.D.Research Proforma

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Pralaapa/Gaadha

Varchasatwam

Indriya uphanana/

Manovyaaharshana/

Bhaya/Shoka/Paani-Pristha-

Shiragraha/Pralaapa/Lomaharsha

Pitta dosha:

Vriddhi Kshaya Prakopa

Darshana Peetavabhasataa/

Peeta Vin-Mutra-

Netra-

Twak/Murcha

Nishprabhataa Paaka/Sweda/Kleda/Kotha/

Sraava/Raga/Murcha

Sparshana Santaapa Mandoshmata Oushnya

Prashna Sheeta kamitva/

Alpanidrataa/Bala

hani/Indriya

dourbalya

Mandaagni Daaha/Kandu/Sadana/Mada/

Katukaayata/Amlaasyata

Kapha dosha:

Vriddhi Kshaya Prakopa

Darshana Shweta twacha-

Mala-

Mutra/Sandhi

vishlesha/Shwasa/

Kaasa

Rukshata/Sandhi

Shaithilya

Shweta Mala-Mutra-

Twak/Utsedha/Sneha upachaya

Sparshana Shaitya/Sthairya Kleda/Shaitya

Prashna Gaurava/

Avasaada/Tandra/

Aalasya/

Agnisaada/

Praseka/

Sandhivishlesha

Trishna/Nidranaasha

/Daurbalya/

Antardaaha/

Hriddrava/Bhrama/

Shleshmaashaya

Shunyata

Kandu/Sthairya/Gaurava/

Upalepa/Alasya/Kleebata/Utsaha

Ph.D.Research Proforma

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Srotas :

Pranavaha : Atisrishtam/Atibadham/Kupita/Alpa-alpa/Abhikshanam/

Sashabdam-sashulam/Shwasa

Annavaha : Anannabhilasha-arochaka/Avipaka/Chardi/Pipasa/Adhmana

Udakvaha : Jihva-Talu-Ostha-Kantha Shosha/Pipasa

Rasavaha : Ashradha/Aruchi/Asyavairasy/Arasajnata/Hrillasa/Gaurava/

Tandra/Angamarda/Jwara/Tama/Panduta/Agnimandya

Raktavaha : Kustha/Visarpa/Pidika/Raktapitta/Raktapradara/Guda-

Medhra asaya paka,Pliha,gulma/Vidradhi/Nilika/Vyanga/

Tilkalaka/Shwitra/Kotha/Rakta mandala

Mansavaha : Sweda/Snigdhangata/Talushosha/Shithilangata/Sita priyata

Kesha-nakhanadi vidradhi/Madhurasayata/Karpada daha

Asthivaha : Asthishula/Dantashula/Bheda/Vaivaranga/Kesha-loma

Nakha nadi shmashru/Sandhishula/Bhrama/Tamodarshana

Murcha/Sthula mula/Arunshi-darshan

Purishvaha : Krichra/Alpa/Sashula/Drava/Grathita/Anaha

Artavavaha : Vadhyatavam/Maithuna asahisnutva/Artava-nasana

Manas Bhava Pariksha:

Manas Bhavas B.T A.T

Moha(Avignanena)

Krodha(Abhidrohena)

Soka(Dainyena)

Bhaya(Vishaadena)

Medha(Grahanena)

Smriti(Smaranena)

Vignana(Vyavasayena)

Harsha(Aamodena)

Priti(Toshena)

Dhairya(Avishaadaena)

Virya(Utthanena)

Avastha(Avibhramena)

Ph.D.Research Proforma

Page xix

Shraddha(Abhiprayena)

Sangna(Naam grahanena)

Hriya(Apatrapanena)

Sheela(Anshilanena)

Dhriti(Alaulyena)

Rajah(Sangena)

Dvesha(Pratishedhena)

Upadhi(Anubandhena)

Manasa(Arthesu

Avyabhicharena)

Mental Status Examination:

S.no. Mental function BT AT

1. Appearance

2. Behaviour

3. Attitude

4. Rapport

5. Mood

6. Speech

7. Thought

8. Perception

9. Consciousness

10. Attention

11. Concentration

12. Memory Recent

Remote

Intermediate

13. Orientation

14. Judgement

15. Insight

Ph.D.Research Proforma

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Hamilton Anxiety Rating Scale

No. Hamilton Anxiety Rating Scale BT AT

1. Anxious Mood

The emotional condition of uncertainty about the future, ranging

from worry, insecurity, irritability and apprehension to

overpowering dread.

2. Tension

Inability to relax, nervousness, bodily tensions, trembling and

restless fatigue.

3. Fears

Fear of being in a crowd, of animals, of being in public places, of

being alone, of traffic, of strangers, of dark,etc.

4. Insomnia

The patient’s subjective experience of sleep duration and sleep

depth during the three preceding nights

5. Difficulties in concentration and memory

Difficulties in concentration, making decision about everyday

matters and memory

6. Depressed mood

Both verbal and non verbal communication of

sadness,depression,despondency,helplessness and hopelessness

7. General somatic symptoms: Muscular

Weakness,stiffness,soreness or real pain, more or less diffusely

localised in the muscles, such as jaw ache or neck ache

8. General somatic symptoms: Sensory

Increased fatigability and weakness or real functional disturbances

of the senses, including tinnitus, blurring of vision, hot and cold

flushes and pricking sensations

9. Cardiovascular symptoms

Tachycardia,Palpitations,oppression,chest pain, throbbing in the

blood vessels and feelings of faintness

10. Respiratory symptoms

Ph.D.Research Proforma

Page xxi

Feelings of constriction or contraction in throat or chest, dyspnoea

or choking sensations and sighing respiration

11. Gastrointestinal symptoms

Difficulty in swallowing, “sinking” sensation in stomach,

dyspepsia(heart burn or burning sensation in the stomach,

abdominal pains related to meals,fullness,nausea and

vomiting),abdominal rumbling and diarrhoea

12. Genito-urinary symptoms

Non organic or psychic symptoms such as frequent or more

pressing passing of urine, menstrual irregularities, anorgasmia,

dyspareunia,premature ejaculation, loss of erection,loss of libido

13. Autonomic symptoms

Dryness of mouth, blushing or pallor, sweating and dizziness

14. Behaviour during interview

The patient may appear tense,nervous,agitated,restless, tremors,

pale, hyperventilating or sweating and dizziness

Total score

Nil/Absent-0, Mild-1, Moderate-2, Severe-3, All symptoms-4

Thus the available adopted score was classified and scored as follow before and after

treatment.

0 to 5-0 5 to 15-1 15 to 25-2 25 to 35-3

>35-4

Vishaada Rating Scale:

Symptoms B.T. A.T.

1. Gatra Sada((Quivering of body or an involuntary

vibration as if from illness or fear)

2. Vepathu(Tremors)

3. Romaharsha(Horripulation)

4. Paridahan(Burning sensation all over body)

5. Na Cha Shaknomi Avasthatum (Unable to stand

steady at one place)

Ph.D.Research Proforma

Page xxii

6. Mano bhraman (Reeling of mind)

7. Anavasthitachittam (Decreased concentration)

8. Dukhatvam(Feeling of Sadness)

9. Avasada (Inability to respond)

10. Nidra Vaishamya (Sleep disturbances)

11. Atmano Ashakta Jananam (Feeling of

inefficiency)

12. Asiddhi Bhayat Apravritti (Atychiphobia)

13. Chittodvega (Anxious mood)

14. Mukhashosha (Dryness of mouth)

15. Prasveda (Sweating)

16. Hridadrava (Palpitations)

17. Aruchi (Lack of desire to take food)

18.Shrama Asahatva (Fatigue unrelated to exertion)

Pathological Investigations:

Haematological Values Biochemical Values

B.T. A.T. B.T. A.T,

Hb% FBS

TLC S.Cholestrol

N S.Tryglyceride

L HDL

E Total Protein

B A/GRatio

M SGOT

ESR SGPT

Others

Urine Examination:

B.T. A.T.

Routine

Microscopic

Others

Ph.D.Research Proforma

Page xxiii

Treatment:

Drug

Dose

Side effect, if any

Follow up:

Guide Scholar

Patients Consent Form for Clinical Trial

Page xxxiii

I, ________________________________ exercise my free favour of choice hereby give my

consent to be treated with ____________________________ subject of clinical trial. I have been

informed to my satisfaction, by the attending physician purpose of clinical trial and the nature of

drug treatment and follow up including laboratory investigations to monitor and safe-guard my

body functions. I am also aware, my right to withdraw from the clinical trial at any time during

the course of trial without having to give the reason of doing so.

qÉæ, _____________________ AmÉlÉÏ xÉWûqÉiÉÏ xÉå mÉëxiÉÑiÉ zÉÉåkÉ MüÉrÉï qÉåÇ xÉÎqqÉÍsÉiÉ WûÉålÉå Måü

ÍsÉL iÉærÉÉU WÕûÆ | xÉqoÉÎlkÉiÉ ÍcÉÌMüixÉMü ²ÉU| qÉÑfÉå __________________ Måü mÉërÉÉåaÉ Måü oÉÉUå qÉåÇ

xÉpÉÏ MÑüNû oÉiÉÉ ÌSrÉÉ aÉrÉÉ Wæû | qÉåUå ²ÉUÉ mÉëS³É xÉqÉxiÉ eÉÉlÉMüÉUÏ MüÉå aÉÉåmÉÌlÉrÉ UZÉÉ eÉÉrÉåaÉÉ LuÉÇ qÉåUå lÉÉqÉ Måü xÉÉjÉ

mÉëxiÉÑiÉ lÉWûÏÇ ÌMürÉÉ eÉÉLaÉÉ | qÉæÇ CxÉ zÉÉåkÉ MüiÉÉï xÉå MüpÉÏ pÉÏ AsÉaÉ WûÉålÉå MüÉ AÍkÉMüÉU UZÉiÉÉ/UZÉiÉÏ WÕðû, ÎeÉxÉMåü

ÍsÉrÉå qÉÑfÉå MüÉåD pÉÏ MüÉUhÉ oÉiÉÉlÉå MüÐ AÉuÉzrÉMüiÉÉ lÉWûÏÇ Wæû |

Å×ú, _____________________ ®ÐгúÕ ÁÐï®ÐÒoÐÒrÐ ÁÐï«ÐïÒ¤ÐoÐ SÐÕÑKúoÁÐÐ £úгúÐ §ÐõÁoÐ×oÐ SÐÕÑKúoÁÐKúÕ¯Ð

A¥Ð×ÁÐï¤ÐХРA¤¯Ð¯Ð¥Ð®ÐÐï »ÐЮÐê¶Ð rºÐÐ ÁÐï®ÐoÐ T×ú. ®Ð¥Ðê §Ðõ ÐÐêPРҺлÐê ÁÐï§ÐÚnÐü ®ÐÐÑÅúoÐÕ AЧÐê¶Ð Têú. ®ÐгúÕ «Ð¤ÐÕ V

®ÐÐÑÅúoÐÕ A¥Ðê ¥ÐЮРPÐקoÐ ³úÐOкÐЮÐÐï AклÐê. SÐÕÑKúoÁÐKúկРA¤¯Ð¯Ð¥Ð sú³ú®¯ÐХРKúÐêC§ÐnÐ úÁoгêú KúÐêC§ÐnÐ KúгúnÐ

AЧ¯ÐРҺХÐÐ A¤¯Ð¯Ð¥Ð®ÐÐïrÐÕ ®Ð×JoÐ rкÐÐ¥ÐÐê ®Ð¥Ðê ÁÐï§ÐÚnÐü AÒ¤ÐKúгú Têú oÐê ҺлÐê Å×ïú WnÐ× T×ïú.

Signature of Physician Signature of Patient Signature of Guide

Randomization Plan

Page xxx

Randomization Plan

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Randomization Plan

Page xxxi

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Randomization Plan

Page xxxii

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100 subjects randomized into 2 blocks

To reproduce this plan, use the seed 23586

Survey Proforma

Page xxiv

Title: A study on Vishada w.s.r to Generalized Anxiety Disorder and its management with

Ashwagandha - a randomised double blind clinical study

Scholar: Dr.Khyati Santwani

Guide: Dr.Anup.B.Thakar

Coguide: Dr.Arun.Khatri

Year: 2009-2011

Patient’s name: Sr.No:

Sex: Male/Female Date:

Age:

Address: Ward/Bed. No:

O.P.D.No:

Religion: H/M/C/J/O I.P.D.No:

Occupation: Housewife/Labour class/Service/Unemployed/Business/

Retired/Student/Other

Education: UE/PE/SE/HS/G/PG Date of Interview:

Family: Nuclear/Joint Marital status: M/UM/W/Divorcee

Socio-economic status: P/LM/M/UM/R Diagnosis:

Habitat: Urban/Suburban/Rural

Department of Panchakarma

Speciality – Manovigyan avum Manas Roga

Institute of Post Graduate Teaching & Research in Ayurveda

Gujarat Ayurved University Jamnagar

SURVEY PROFORMA

Survey Proforma

Page xxv

Diet History:

Ahara: Samisha (Non-veg) Niramisha (Veg)

Ahara pramana: Alpa Sama Ati

Kshudha: Alpa Madhyam Ati

Trishna: Alpa Madhyam Ati

Ahara: Dominant Rasa: M / A / L/ K / T / Ks

Dominant Guna: G / L / Sh / U / Sn / R

Abhyavarana shakti Jarana Shakti

Aavara Avara

Madhyama Madhyama

Pravara Pravara

Viruddhahara (Incompatible diets)

Desha Viruddha – Yes No

Were/are you routinely taking dry (ruksha) and sharp (tikshna)

substances in jangala desha?

Were/are you routinely taking unctuous (snigdha) and cold (sheeta)

substances in anupa desha?

Kala Viruddha –

Were/are you routinely taking cold and dry substances in winter?

Were/are you routinely taking hot and pungent substances in

summer?

Agni Viruddha –

Were/are you routinely taking heavy food even when the power

of digestion is mild (mandagni)?

Were/are you routinely taking light food even when the power

of digestion is sharp(tikshnagni) ?

Matra Viruddha –

Were/are you routinely taking honey and ghee in equal quantity?

Survey Proforma

Page xxvi

Satmya Viruddha –

Were/are you routinely taking substances having qualities opposite to

the accustomed ones?

Dosha Viruddha –

Were/are you routinely taking diet having similar qualities

with the doshas but at variance with the habit?

Samskar Viruddha –

Were/are you routinely taking improperly processed food

Virya Viruddha –

Were/are you routinely taking hot and cold diet at the

same time together?

Kostha Viruddha –

Were/are you routinely taking mild purgative in a small dose inspite of

having a costive bowel?

Were/are you routinely taking strong purgatives inspite of having a

laxed bowel?

Avastha Viruddha –

Were/are you routinely taking Vata aggravating diet

after exhaustion, sexual act or physical exercise?

Were/are you routinely taking Kapha aggravating diet

after sleep or drowsiness?

Krama Viruddha –

Were/are you routinely taking food before your bowel

and bladder were clear?

Were/are you routinely taking food inspite of having no

hunger or after having aggravated hunger?

Parihara Viruddha/Upchara Viruddha –

Were/are you routinely taking hot things after eating

meat or pork?

Were/are you routinely taking cold things after taking ghee?

Survey Proforma

Page xxvii

Paka Viruddha –

Were/are you routinely accustomed to take preparation of food

with bad or rotten fuel?

Were/are you routinely taking food which was undercooked,

Overcooked or burnt during the process of preparation?

Samyoga Viruddha –

Were/are you routinely taking sour substances with milk?

Were/are you routinely taking milk with khichdi?

Hridaya Viruddha –

Were/are you routinely taking food which is not pleasant

in taste or which is not of your choice?

Sampad Viruddha –

Were/are you routinely taking substances that are not

matured or over matured or putrified?

Vidhi Viruddha –

Were/are you routinely taking meals in public or

buffet dinners?

Dushta Ahara (Diet whose natural properties are modified by various processes)

Were/are you routinely taking over ripen fruits, vegetables?

Were/are you routinely taking over ripe curd?

Were/are you routinely taking Ghrita kept in a bronze vessel

for more than 10 days?

Were/are you routinely taking dehydrated or frozen food?

Were/are you routinely taking microwave cooked food regularly?

Were/are you routinely reheating the previously cooked food?

Were/are you routinely taking canned foods?

Were/are you routinely taking bakery items or items made of

refined flour?

Were/are you routinely taking packaged high-calorie snack foods

Survey Proforma

Page xxviii

like chips and cheese snacks?

Ashuchi Ahara(Impure Ahara)

Were/are you routinely taking stale water (Water kept for many days)

Were/are you routinely taking food items like vegetables, fruits, grains,

etc. without cleaning them properly?

Were/are you routinely taking food in laris (road vendors)?

Foods as per action on mind

Satwika food Rajasika food Tamasika food

Fresh fruits: mango,

pomegranate, coconut, figs,

peaches, pears, grapes, apple,

apricots, sapota, sweet lime,

dates, papaya, watermelon,

banana etc.

Fresh vegetables: Ladies finger,

bitter guard, horse gram,

capsicum, corn, lentil, double

beans, pumpkin, sweet potato,

coriander leaves, fenugreek,

carrots, beet root

Fresh dairy: Milk, butter,

clarified butter (ghee), cheese

(paneer), whey and yogurt

Nuts, seeds: Almonds (especially

when peeled and soaked in water

overnight), coconut, pine nuts,

walnuts, sesame seeds, pumpkin

seeds and flax seeds.

Deep fried foods

Too much cooked food

Sour fruits: Oranges, grapefruit,

lemons, guava

Vegetables :Cauliflower,

broccoli, spinach, tamarind,

onion

Pickles, fresh fish, shrimp, white

meat chicken.

Coffee, tea, cola drinks,

chocolate, salt.

Spices: Black pepper, red pepper

and garlic

Stale, tasteless, rotten and

Impure foods

Strongly processed, canned or

frozen foods

Fruits :Avocado, watermelon,

plums and apricots

Vegetables: Mushrooms,

pumpkin and all genetically

modified products.

Cereals :Urad dal, black beans,

pink beans

Meat: Pork, beef, lamb, dark

meat chicken, fish and lobster

Canned, dried, frozen or old

flesh products

Eggs

Alcoholic beverages

Survey Proforma

Page xxix

Oils: Olive oil, sesame oil and

flax oil.

Whole grains: Organic rice,

whole wheat, spelt, oatmeal and

barley.

Khichdi ,kheer, chapatis,

porridge

Legumes: Split mung beans,

yellow split peas, organic tofu,

bean sprouts, lentils

Spices: Basil, cardamom,

cinnamon, coriander, cumin,

fennel, fenugreek, fresh ginger

and turmeric.

Guide Scholar