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CTRI Number  CTRI/2026/02/105027 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 26/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   ALCOHOLIC DISORDER 
Scientific Title of Study   ADD-ON EFFECT OF DRAKSHARISTA TO THIAMINE IN THE MANAGEMENT OF ALCOHOL USE DISORDER-A RANDOMIZED DOUBLE BLIND CONTROLLED STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr RajimunnisaBegam Shaik 
Designation  Associate Professor, Department of Kayachikitsa Manasroga 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi 
Address  Department of Kayachikitsa Manasroga, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi, Karnataka 590003
Department of Kayachikitsa Manasroga, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi, Karnataka 590003
Belgaum
KARNATAKA
590003
India 
Phone  7019454157  
Fax    
Email  dr.razia.sk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RajimunnisaBegam Shaik 
Designation  Associate Professor, Department of Kayachikitsa Manasroga 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi 
Address  Department of Kayachikitsa Manasroga, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi, Karnataka 590003
Department of Kayachikitsa Manasroga, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi, Karnataka 590003
Belgaum
KARNATAKA
590003
India 
Phone  7019454157  
Fax    
Email  dr.razia.sk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr RajimunnisaBegam Shaik 
Designation  Associate Professor, Department of Kayachikitsa Manasroga 
Affiliation  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi 
Address  Department of Kayachikitsa Manasroga, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi, Karnataka 590003
Department of Kayachikitsa Manasroga, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi, Karnataka 590003
Belgaum
KARNATAKA
590003
India 
Phone  7019454157  
Fax    
Email  dr.razia.sk@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kanakanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi, Karnataka, India 590003 
 
Primary Sponsor  
Name  Dr RajimunnisaBegam Shaik 
Address  Department of Kayachikitsa Manasaroga, KAHERs Shri B M Kanakanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi, Karnataka, India 590003 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 RajimunnisaBegam Shaik  KLE Ayurveda Hospital and Medical Research Centre Belagavi  OPD NO. 13 of KLE Ayurveda Hospital and MRC KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 Belgaum KARNATAKA Belgaum KARNATAKA
Belgaum
KARNATAKA 		 7019454157

rajimunnisabegam.kaher@kleayurworld.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B.M.Kankanwadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital, Shahapur, Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: MADATYAYA-ARISHTAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Thiamine, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 100(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Draksharita, Reference: 22. Trikamji Jadavaji Vaidya , Ayurveds Dipika , Charaka samhita ,chikits sthan,chapter 24, shloka 108-111,vol.2,Chaukhamba Subharti Prakashan , Varansi , Reprint: 2009, p587. , Route: Oral, Dosage Form: Arishta, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
3Comparator Arm (Non Ayurveda)-ThiamineReference: NA, Route: Oral, Dosage Form: Capsules, Dose: 100(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes
4Comparator Arm (Non Ayurveda)-PlaceboPlacebo BID
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age group 20-50 years
Patients clinically diagnosed on the basis of Samanaya Madatyaya Lakshanas and on the basis of Criteria of Alcohol Use Disorder according to DSM-V ICD-11(Code 6C40 Z)
Patients will be selected randomly irrespective of gender economical educational and marital status
Patients who are willing to provide written informed consent with desire to stop the alcohol abuse
 
 
ExclusionCriteria 
Details  Patients with severe Alcohol Use Disorder as per AUDIT scoring more than 31
Highly violent patients and Patients suffering from major psychiatric illnesses like Major depressive disorder Schizophrenia Psychosis and Epileptic disorders
Patients with any kind of major systemic illness such as Malignancy Diabetes CVD HIV TB etc
Patients withLiver failure Liver Cirrhosis Hepatic necrosis Hepatitis Cerebral degeneration
Pregnant ladies and lactating mothers
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
AUDIT SCALE, Liver parameters like Liver Function Test and the gamma-glutamyl-transferase test in Alcohol Use Disorder.
To evaluate the add-on effect of Mahakalyanaka vati capsules on Sleep, Cognition, depression, and side effect profile of Alcohol use Disorder by ISI, MoCA, HAM-D, UKU side effects rating scale.
 		 Baseline,4 weeks, and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the add-on effect of Mahakalyanaka vati capsules on WHOQOL-BREF
 		 On baseline 0th day and 60th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/04/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included PUBLICATION).

  6. For how long will this data be available start date provided 05-09-2025 and end date provided 26-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

As per Ayurvedic texts, the disease caused by the abuse of alcohol is called Madatyaya, which presents with clinical features similar to alcoholism. Madatyaya is a Tridoshaj disorder with Vataj, Pitta, Kapha, and Sannipataj types. Treatment typically begins at the site of Kapha, as it is predominantly affected, along with Pitta and Vata.

Alcohol Use Disorder (AUD) is characterized by a strong internal drive to consume alcohol, impaired control over use, prioritization of alcohol over other activities, and persistence despite harmful consequences. People with AUD are at increased risk of liver cirrhosis, pancreatic disease, and accidents. Globally and in India, AUD contributes significantly to morbidity and mortality, with a large proportion of affected individuals requiring treatment.

Excessive alcohol consumption directly affects the Hriday, impacting both physical and psychological health through the Rasavaha and Manovaha Srotas. Conventional management of AUD ranges from psychotherapy to pharmacological interventions, but these drugs often have contraindications, and a universally effective treatment is lacking.

Ayurvedic therapies have shown protective effects on alcohol dependence, withdrawal anxiety, and liver health, acting as hepatoprotective and antioxidant agents. In Ayurveda, Madatyaya involves vitiation of both Shareerika and Manasika Doshas, affecting physical, psychological, social, and occupational well-being. Management primarily includes Doshavsechana, Rasayana, and Satvavajaya Chikitsa. Preparations like Karjuradhi Mantha have Rasayana and Ojovardhana properties, while Virechana aids in Dosha elimination, pitta reduction, and gut microbiota improvement.

The present study has been designed to evaluate an integrative Ayurvedic treatment protocol, including Satvavajaya Chikitsa, pathya-apathya, and a Yoga regimen, for the management of Madatyaya (alcohol dependence).

 
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