FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/10/046674 [Registered on: 20/10/2022] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [YOGA, DIET AND Sattvavajaya Chikitsa/COUNSELLING TECHNIQUE]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurveda Management Protocol in Madatyaya/Alcoholism(Alcohol Dependence) 
Scientific Title of Study   A Comparative Multi-modal study of Drakshadi Kashaya over Mrudweekadi Kashaya in Madatyaya (Alcohol Dependence) - A Randomized controlled clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohit 
Designation  PG Scholar 
Affiliation  KAHERs Shri BMK Ayurved Mahavidhyalaya Shahapur Belagavi 
Address  Department of Kayachikitsa OPD No.- 03,14 KAHERs Shri BMK Ayurved Mahavidhyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  8295191673  
Fax    
Email  drmohit725@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suhas Kumar Shetty 
Designation  Principal (MD, PH.D.) and Professor, Deptartment of Kayachikitsa 
Affiliation  KAHERs Shri BMK Ayurved Mahavidhyalaya Shahapur Belagavi 
Address  Department of Kayachikitsa OPD room no.-14 KLE Ayurveda Hospital, KAHERs Shri BMK Ayurved Mahavidhyalaya Shahapur Belagavi
KAHERs Shri BMK Ayurved Mahavidhyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India 
Phone  9449603234  
Fax    
Email  drsuhasshetty@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohit 
Designation  PG Scholar 
Affiliation  KAHERs Shri BMK Ayurved Mahavidhyalaya Shahapur Belagavi 
Address  Department of Kayachikitsa OPD No.- 03,14 KLE Ayurveda Hospital, KAHERs Shri BMK Ayurved Mahavidhyalaya Shahapur Belagavi
Department of Kayachikitsa OPD No.- 03,14 KAHERs Shri BMK Ayurved Mahavidhyalaya Shahapur Belagavi
Belgaum
KARNATAKA
590003
India 
Phone  8295191673  
Fax    
Email  drmohit725@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri BMK Ayurved Mahavidhyalaya, Shahapur, Belagavi, Karnataka 
 
Primary Sponsor  
Name  Dr Mohit 
Address  KAHERs Shri BMK Ayurved Mahavidhyalaya, Shahapur, Belagavi, Karnataka 
Type of Sponsor  Other [[Self sponsored PG dissertation work]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohit  KLE Ayurveda Hospital KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahapur Belagavi KARNATAKA  Department of Kayachikitsa OPD No.- 03,14 KLE Ayurveda Hospital KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahapur Belagavi KARNATAKA
Belgaum
KARNATAKA 
8295191673

drmohit725@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics committee for research on human subjects  Approved 
Institutional Ethics committee for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F102||Alcohol dependence. Ayurveda Condition: MADATYAYAH/PANATYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Mrudweekadi Kashaya, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Drakshadi Kashaya, Reference: Ashtang Hridya in context of Jawara Chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  ï‚·Patients of age group 20-50 years visiting the KLE BMK Hospital OPD & IPD .
ï‚·Patients clinically diagnosed on the basis of Samanaya Madatyaya Lakshanas and on the basis of Criteria of Alcohol Dependence according to ICD-11.
ï‚·Patients will be selected randomly, irrespective of gender, economical, educational and marital status.
ï‚·Patients who are willing to provide written informed consent with desire to stop the alcohol abuse. 
 
ExclusionCriteria 
Details  ï‚·Patients with severe Alcohol Dependence as per ADS scoring>31.
ï‚·Highly violent patients and Patients suffering from major psychiatric illness like Major depressive disorder, Schizophrenia, Psychosis and Epileptic disorders.
ï‚·Patients K/C/O any kind of major systemic illness such as Malignancy, Diabetes, CVD ,HIV, TB etc.
ï‚·Patients K/C/O Hepatitis and Hepatic necrosis(ALT>10times Upper Reference Limit and Bilirubin>10 times Upper Reference Limit), Liver failure(ALT and AST>10times Upper Reference Limit),Liver Cirrhosis,Cerebral degeneration.
ï‚·Pregnant ladies and lactating mothers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in signs and symptoms of Madatyaya.  30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in GGT (Gamma-gultamyltransferase), Liver Function parameters and
Madatyaya Lakshanas achieved. Further, Alcohol Consumption will be reduced. 
30 Days 
 
Target Sample Size
Modification(s)  
Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
02/06/2023 
Date of Study Completion (India) 17/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 17/05/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

As per the Ayurvedic texts the disease caused by the abuse of Madya (alcohol) is called as Madatyaya (alcoholism) and its clinical symptoms are similar to Alcoholism.

Madatyaya is Tridoshaj vyadhi having Vataj, Piitaj, Kaphaj and Sannipataj types. The treatment of madatyaya shall begin with the site of kapha, as it is predominantly situated , lined by pitta and vata.

Alcohol dependence is a disorder of regulation of alcohol use, arising from repeated or continuous use of alcohol. The   characteristic feature is a strong internal drive to use alcohol, which is manifested by impaired ability to control use, increasing priority given to the use over other activities and persistence of use despite harm or negative consequences.

People with alcohol dependence are at increased risk of liver cirrhosis, pancreatic disease, and accidents.

In 2016, 3 million deaths or 5.3 percent of all global deaths (7.7 percent for men and 2.6 percent for women), were attributable to alcohol consumption.

Of all Alcohol-related deaths Worldwide in 2016, injuries accounted for 28.7% of fatalities, followed by digestive illnesses (21.3%), cardiovascular diseases (19%), infectious diseases (12.9%), and malignancies (12.6%). About 49% of alcohol attributable DALYs are due to non-communicable and mental health conditions.

Alcohol dependence is a major problem in India. An estimated 34–42% of the adult Indian population reports having used alcohol in their lifetime; 5–7% have been estimated to use alcohol, and 10–20 million people have been estimated to be in need of treatment for alcohol dependence.

Roughly 14.6% of the population, in the country (aged 10 to 75), are current drinkers.  About 5.2% of the population, are thought to be impacted by hazardous or dependent alcohol usage. In India, every third alcoholic requires assistance for alcohol-related issues.

 According to the National Mental Health Survey of India 2015–16, 9% of adult men have AUDs. Alcohol was determined to be responsible for 5.4% of all cause deaths in India. Alcohol usage was to blame for about 62.9% of all liver cirrhosis-related deaths.

Problems related to alcohol consumption made up to 17.6% of psychiatric emergencies in an Indian general hospital.

The classic text of Ayurved quotes a similar Vyadhi, Madatyaya with its types, symptoms and treatment. Excessive consumption of Madya directly affects ‘Hriday’ which is one of the vital organs of the body and it is predominantly associated with the Rasavaha and Manovaha Srotas.

Conventional management of AUD includes Psychotherapy to Pharmacological intervention which includes antidote preparation, anti-epileptic drugs, neurotransmitter inhibitors, neuro protectors etc.

However there are numerous contraindications of the drugs  like Liver and Renal disease, Polyneuropathy etc. that makes those drugs irrational and ideal effective drug for all types of alcoholic patients does not exist, the future challenge will consist in tailoring personalized treatments.

Ayurvedic drugs has demonstrated protective effect on alcohol dependence and withdrawal anxiety in previous experimental studies and their action on liver is well established as hepato protective, antioxidants in alcohol induced stress.

There are many Shamana Oushadis in Ayurveda, Drakshadi Kashaya is one among them. It has the property of Tridoshahara, Deepana, Pachana, Rasayana, Seetaveerya pradhana, Balya, Medhya, Hrudyabalaprada, Yakritduttejaka, Chardi nigrahana and trishna nigrahana.

Drakshadi Kashaya has been told useful in Murcha(Fanting), Bhrama(Giddiness) like Manas Vikara(Psychological) in which Hrudya is affected and in Madatyaya(Alcoholism), Kamala(Jaundice) in which Liver is primarily affected, also in Alcohol users Liver got affected and is psychological too. So this is an effort taken to study the clinical effect of Drakshadi Kashaya as Medhya(Nootrophic), Hrudyabalaprada, Rasayana(Rejuvinating effect) and Yakritduttejaka(Hipatoprotective) in Madatyaya(Alcohol Dependence).

Hence, current study has been planned to evaluate the efficacy of Ayurveda treatment protocol which has integrative approach including Satwavajaya chikitsa, pathya-apathya and Yoga Protocol in the management of madatyaya (Alcohol dependence).

 
Close