“A COMPARATIVE CLINICAL STUDY ON ELADI MODAKA AND KHARJURADI MANTH IN MADATYAYA WITH SPECIAL REFERENCE TO ALCOHOL WITHDRAWAL SYNDROME”

PLAN FOR DISSERT ATION

submitted to

Dr. SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY JODHPUR (RAJASTHAN)

For the degree of

AYURVEDA VACHASPATI (M.D. Ayu-2022)

Post Graduate Department of Agad Tantra and Vyavahar Ayurveda

Under the Supervision & Guidance

GUIDE

CO-GUIDE

SCHOLAR

Prof. Anita Sharma

Dr. Amol Kadu

Dr. Sunita Yadav

M.D., PhD (Ayu.)

M.D. (Ayu)

M.D. Scholar

Professor

Lecturer

P.G. 1st year

& HOD

P.G. Department of Agad Tantra and Vyavahar Ayurveda

National Institute of Ayurveda, Jaipur

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Application For Dissertation

To

The Registrar,

Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur

Through: - Proper Channel

Subject: - Requesting for Registration of the dissertation for the award of Ayurveda Vachaspati

[M.D.(Ayu.)] in Agad Tantra and Vyavaharayurveda in the session 2019-2022

Respected Sir,

With due respect, I would like to present following particulars and also enclose the revised

synopsis of the dissertation with this application for your kind perusal and permission please.

Name of Scholar - Dr. Sunita Yadav

Father’s Name - Shri. Rajender Prasad

Date of Birth - 05/05/1994

Permanent add. - Opposite petrol pump guryani road V.P.O Kosli Dist. Rewari Previous Exam Passed. B.A.M.S. (2017), C.D.L. collage of Ayurveda, Yamuna Nagar Enrolment Number - Applied for

Name of Department - P.G. Department of Agad Tantra Name of Institute - National Institute of Ayurveda, Jaipur Language of Dissertation - English, Sanskrit

Title of Dissertation - “A comparative clinical study on Eladi Modaka and Kharjuradi Manth in Madatyaya with special reference to Alcohol withdrawal syndrome”

Under the Supervision & Guidance

GUIDE CO-GUIDE SCHOLAR

Prof. Anita Sharma

Dr. Amol Kadu

Dr. Sunita Yadav

M.D., Ph.D. (Ayu.)

M.D. (Ayu.)

M.D. Scholar

Professor

Lecturer

P.G. 1st year

& HOD

P.G. Department of Agad Tantra and Vyavahar Ayurveda

National Institute of Ayurveda, Jaipur

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‘A COMPARATIVE CLINICAL STUDY ON ELADI MODAKA AND KHARJURADI MANTH IN MADATYAYA WITH SPECIAL REFERENCE TO ALCOHOL WITHDRAWAL SYNDROME’

INTRODUCTION:

Addiction is a psychological and physical inability to stop consuming a chemical, drug, activity or substance even though it causes psychological and physical harm. Most of the people start using a drug or first engage in an activity voluntarily. However, addiction can take over and reduce self-control. Every year addiction to alcohol costs the economy upward of $740billion in treatment cost, unemployment and effect of crime. The per capita alcohol consumption in India increased two folds between 2005 and 2016, according to the Global status report on alcohol and health 2018 released by the World Health Organization.

Use of alcohol is no doubt of immemorial antiquity and is a part of social and cultural life. Alcohol abuse is not only having impact on individual and families, but creates a lasting social burden on the community and even national level. When a chronic- alcoholic tries to reduce or completely impede the alcohol intake, then a cluster of symptoms manifests which is called as alcohol withdrawal syndrome (AWS). The symptoms include nausea, vomiting, sweating, headache, irritability, anxiety, agitation, auditory visual and tactile hallucinations, delirium tremens, seizures etc. Mentioning on the note, alcohol abuse or alcohol dependence were the two different disorders described in diagnostic and statistical manual (DSM IV).

They have now been integrated into a single disorder called alcohol used disorder (AUD)with mild, moderate and severe sub classification described in the new guidelines of DSM V.

In Ayurveda disease related to alcohol are counted under Madatyaya. The disease Madatyaya can be studied through various aspects, in view of light, notably it aggravates mainly due to excessive heavy drinking in Tamo guna pradhana persons resulting in slow down or abolishing the jatharagni with further accumulation of Aama or undigested food inside the kostha resulting in kapha vata prakopa further obstructs the strotasas and gradually leads to tridosh prakopa resulting in sannipataja vyadhi MADATYAYA.

The treatment of Madatyaya focuses on Doshavsechan, Santarpana, Rasayana and Satvavjaya chikitsa. Eladi Modaka is one such Yoga mentioned in Bhiasajaiya Ratnavali in context of Madatyaya. In this yoga there are 18 major drugs with wide range of action.Firstly drugs like Pippali, Chitrak mool, Ela act as Deepana, Pachana, Aruchighana and also pacifies Kafa Vatta doshas. Draksha, Kharjoor, Vidarikanda, Tila, are Santarpanajanya dravyas, providing Bala and reduces Vata Pitta doshas further reducing symptoms like tremors, agitation anxiety etc and craving by acting on Tamo guna. Haridra, Daruharidra, Ela, plays a major role in pacifying all three doshas and thus detoxifing the body. The pacified doshas are then eliminated from the body in form of waste products, this can be amplified with Gokshura beeja, lastly Shatavari, Triphala and Kharjura act as Rasayana and Vajikarana .so, keeping in mind the integrated effect of the Yoga. So, with the intension of providing a better and a safer drug a study will be carried out with internal administration of Eladi Modaka in the Alcohol Withdrawal Syndrome.

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PREVIOUS STUDIES-

1. Dr. Sandeep Charak, Clinical efficacy of Narayanachurna in Alcohol Addiction; A randomized control clinical trial’ studied at NIA Jaipur.

2. Dr. Anjali Sheokand, “Clinical efficacy of Ashwagandharishta in madatyaya w.s.r. to Alcoholism” studied at NIA Jaipur.

3. Dr.Anshu Malviya “A Randomized controlled clinical trial of Pueraria tuberosa and herbal formulation in Alcohol Addiction” studied at NIA Jaipur. .

4. Dr. Pradeep kumar, “clinical study to evaluate the effect of shreekhandasava in madatyaya w.s.r. to Alcohol used disorder” studied at SDM college Udupi, Karnataka.

5. Dr. Akeeb jawed “clinical study to evaluate the role of kharjuradi manth in enhancement of Oja guna in Madatyaya” studied at Govt. Ayurvedic college Mysore, Karnataka.

HYPOTHESIS

NULL HYPOTHESIS [Ho]

• There is no difference in the efficacy of Eladi Modaka and Kharjuradi Manth in common symptoms of Madatyaya on basis of (CIWA-Ar) scale.

NEED OF THE STUDY:

➢ Alcoholism is a very big rising problem in the world. The per capita consumption of alcohol in the country increased from 1.6 litters from the period of 2005 to 2010 to 2.2 glitters from the period of 2010-2012. It was revealed that over 11% of population in India indulge in heavy or binge drinking, the global figure stood at 16%.

➢ The clinical manifestation and management of Alcohol Withdrawal Syndrome is available in Brihattrayi & laghutrayi in sutra form, the main lacuna in the management of alcohol addicted patients is that there is no valid protocol for the de- addiction of alcohol in Ayurveda and it is need of time to develop, evaluate and elaborate the different management protocols in the present contemporary time.

➢ Alcohol used disorder is the most prevalent and debilitating psychiatric disorders among the general population affecting people of all walks of life due to its wide availability and acceptance in all cultures. It’s often at the centre of social situations and closely linked to celebrations and enjoyment. People get easily attracted to this

changing western culture which at the end results in stress, depression, exhaustion and increase intake of alcohol consumption. Therefore, it is the need to abstain such practice.

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AIMS

• To compare the efficacy of Eladi Modaka with Kharjuradi Manth in Alcohol Withdrawal Syndrome.

OBJECTIVE:

• To study the clinical efficacy of Eladi Modaka in alcohol withdrawal syndrome.

• To study the clinical efficacy of Kharjuradi Manth in Alcohol Withdrawal Syndrome.

LITERATURE REVIEW:

All the literature regarding this is reviewed from Brihattrayi, Laghutrayi and available commentaries of those text of modern medical sciences referred along with published relevant research articles.

MATERIALS AND METHODS:

CONCEPTUAL STUDY

a. A review of Alcohol Withdrawal Syndrome from Ayurvedic classics, texts, research journals and recently published books.

b. A comprehensive review of the disease from Modern science.

STUDY DRUG

Drug will be prepared in pharmacy by means of classical methods.

1. ELADI MODAKA: described in Bhaishajya Ratanavali in context of Madatyaya (page no. 496, shloka no. 21 to 24)

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Sr.no.

Drug name

Botanical name

Part used

Quantity

1.

Suksma ela

Eletaria cardamomum

Maton.

Seed

1 PART

2.

Madhuka

Madhuka indica J.F.Gmel

Flower

1 PART

3.

Citrakamula

Plumbago Zeylanicum Linn.

Root

1 PART

4.

Haridra

Curcuma Longa Linn.

Tuber

1 PART

5.

Daruharidra

Berberis Aristata DC.

Root, stem, fruit

1 PART

6.

Haritki

Terminalia Chebula Retz.

Fruit

1 PART

7.

Vibhitki

Terminalia Bellirica (Roxb.)

Fruit

1 PART

8.

Amalika

Emblica Officinals Gaertn

Fruit

1 PART

9.

Rakta Sali

Oryza longistaminata

Fruit

1 PART

10.

Pippali

Pipper Longum Linn.

Fruit

1 PART

11.

Draksa

Vitis Vinifera Linn.

Fruit

1 PART

12.

Kharjura

Phoenix Sylvestris Roxb.

Fruit

1 PART

13.

Tila

Sesamum Indicum Linn.

Seed

1 PART

14.

Yava

Hordeum Vulgare

Seed

1 PART

15.

Vidari

Pueraria Tuberose DC.

Tuber

1 PART

16.

Goksura

Tribulus Terrestris Linn.

Seed

1 PART

17.

Trivrit

Operculina terpethum Linn.

Root bark

1 PART

18.

Satavari

Asperagous racimosus Willd.

Tuber

1 PART

19.

Sugar

36 PARTS

20.

Water

SOS

Method of preparation: Fine powder will be prepared by taking all the ingredients. Take the sugar in a stainless-steel vessel and add water to it then boil it till the consistency of the confectionery. Then add the earlier prepared fine powders to it and roll the mixture to prepare its Modaka of 10gm by weight.

2. KHARJURADI MANTH: described in Charak Sutrasthan (23/38)

S.no.

Drug name

Botanical name

Part used

Quantity

1.

Kharjura

Phoenix Sylvestris Roxb.

Fruit

1 Part

2.

Draksa

Vitis Vinifera Linn.

Fruit

1 Part

3.

Vrikshamla

Garcinia Indica

Fruit

1 Part

4.

Amalika

Emblica Officinals Gaertn.

Fruit

1 Part

5.

Chincha

Tamarindus Indica Linn.

Fruit

1 Part

6.

Dadima

Punica Granatum Linn.

Fruit

1 Part

6

7.

Parushaka

Grewia Assiatica Linn.

Fruit

1 Part

Method of preparation: Fresh ingredients are collected in equal parts and soaked in 4 parts water for about an hour. These are then crushed and churned manually. The mixture is stained and served along with sugar to taste.

DRUG DOSAGE: both the drugs will be administered orally.

1. Eladi modaka: 10g twice a day for 30 days with 100ml Godugdha

Dose:10g BD

Duration:30 days

Anupana: Godugdha (100ml)

2. Kharjuradi manth: 100ml twice a day for 30 days

Dose: 100ml

Duration:30 days

CLINICAL STUDY

STUDY DESIGN:

• Study type: Randomised Comparative Clinical Trail

• Study design: Open label

• Timing: Prospective

• End point: safety and efficacy

• No. of group: two

PLAN OF THE STUDY:

SAMPLE SIZE: Since the study requires optimum amount of time and money on giving main emphasis on the feasibility and looking at the time duration total 30 subjects will be randomly selected for the study, with the age group lying b/w 18yrs to 70yrs, irrespective of sex, religion etc.

SOURCE OF SUBJECTS:

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Clinically diagnosed and registered patients attending the OPD of National Institute of Ayurveda, Jaipur (Raj.) the patients will be assessed on the bases of AUDIT (Alcohol Used Disorder Identification Test) scale provided by DSM V based on its new guidelines.

INFORMED CONSENT:

A fully interrogated and diagnosed patients will be selected. They will be explained about the nature of the disease and the possible withdrawal symptoms along with the treatment regarding the alcohol used disorder. Then signed, written informed consent will be taken from each patient before starting the trial.

CRITERIA FOR SELECTION

A. Inclusion Criteria:

ï‚¢ Patients of age group 18-70 years visiting the NIA, hospital OPD and willing to provide written, informed consent with desire to stop the alcohol abuse will be selected for the study clinically diagnosed on the basis of AUDIT scale (> 15) provided by DSM V based on its new guidelines with relevant parameters.

ï‚¢ Patients will be selected randomly, irrespective of gender, economical, educational and marital status.

B. Exclusion Criteria:

ï‚¢ Patients with severe clinical manifestation of Alcohol Withdrawal Syndrome.

ï‚¢ Highly violent patients, not following the proper instructions given to them or suffering from major psychiatric illness.

ï‚¢ Patients suffering from any kind of major systemic illness such as Malignancy, Diabetes, Cardiac disorder, HIV, pulmonary TB etc.

ï‚¢ Patients suffering from liver failure, hepatic necrosis, hepatitis B and C, cerebral degeneration.

ï‚¢ Pregnant ladies and lactating mothers.

C. Criteria for Withdrawal:

ï‚¢ Intolerance to therapy.

ï‚¢ Unwillingness to continue with the study.

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ï‚¢ Patients with irregular follow-up.

ï‚¢ Development of any condition requiring any other specific management.

DIVISION OF THE GROUPS:

Grouping for Clinical Study: 30 clinically diagnosed and registered patient of Alcohol Withdrawal Syndrome will be divided randomly into two groups. Each group will have 15 patients.

Group (A) :15 clinically diagnosed and registered patient of Alcohol Withdrawal Syndrome will be treated with Eladi Modaka by oral administration.

Duration –30 days

Dose– 10g twice a day orally

Anupana- Godugdha(100ml)

Group (B): 15 clinically diagnosed and registered patient of Alcohol Withdrawal Syndrome will be treated with Kharjuradi Manth by oral administration.

Duration – 30 days

Dose -100 ml, twice a day.

ASSESSMENT CRITERIA

1. Assesment Of Craving of Alcohol

The craving of alcohol in a patient is asses by the scale called Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R)i. It is a scale of 12 question with 7 greading of each question. Greading one indiacate strongly disagree and 7 indicate strongly agree. Greading 4 means neutral, when we go towards 5, 6,7 it shows strength of agreement and when we go towards 3,2,1 it shows strength of disagreement. The score of question no. 3,8 and 11 are reverse i.e. it start from 7 and end at 1. A genral craving index is derived by summing all the score divided by 12.

Question

Study group (Group. A)

Control group (Group. B)

Before

Treatment

After

Treatment

Before

Treatment

After

Treatment

1. If I had some alcohol, I would

probably drink it. (0-7)

2. I miss drinking? (0-7)

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3 I am not making any plans to drink.? (0-7)

4 I could not stop myself from drinking if I had some alcohol

here.? (0-7)

5. I want to drink so bad I can almost taste it.?

(0-7)

6. I would feel less irritable if I

used alcohol now? (0-7)

7. If I used alcohol, I would feel

less tense? (0-7).

8. Drinking would not be very

satisfying? (0-7)

9. I would feel less restless if I

drank alcohol? (0-7)

10. If I were using alcohol, I would feel less nervous.? (0-7)

11. It would be easy to pass up the chance to use alcohol.? (0-

7)

12. Drinking would put me in a

better mood? (0-7)

.

Clinical Assessment of Alcohol Withdrawal Syndrome Patients (as per CIWA-Al)

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Clinical features

Study group (Group. A)

Control group (Group. B)

Before

Treatment

After

Treatment

Before

Treatment

After

Treatment

Nausea/Vomiting (0-

7)

Tremors (0-7)

Anxiety (0-7)

Agitation (0-7)

Paroxysmal sweat (0-

7)

Orientation & clouding of sensorial

(0-4)

Tactile disturbances

(0-7)

Auditory disturbances

(0-7)

Visual disturbances

(0-7)

Headache (0-7)

1. Pathological Assessment in Alcohol Withdrawal Syndrome Patients

Test

Study group (Group. A)

Control group (Group. B)

Before

Treatment

After Treatment

Before

Treatment

After

Treatment

CBC:

HB%

LFT:

Serum Bilirubin (T)

Serum Bilirubin (D)

SGOT

SGPT

Serum protein

OBSERVATIONS & RESULTS:

A detail proforma will be created to carry out this study in a scientific way. All demographic data related to patient along with sign & symptom of Alcohol Withdrawal Syndrome will be noted on 1st day,15th day & 30th day and pathological assessment will be done in 1stday & 30th day of the study. The result will be presented in form of table, graph and diagram. Data obtained during the study will be analysed statistically by using appropriate test of significance suitable for the study. It is considering the 1st day as before treatment and 30th day after treatment.

SUMMARY AND CONCLUSION:

The finding as observation and result will be summarized and conclusion will be carried out on the basis of observations and results.

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