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ALCOHOLIC DISORDER

ADD-ON EFFECT OF DRAKSHARISTA TO THIAMINE IN THE MANAGEMENT OF ALCOHOL USE DISORDER-A RANDOMIZED DOUBLE BLIND CONTROLLED STUDY - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/105027
Enrollment
40
Registered
2026-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E889- Metabolic disorder, unspecified

Interventions

None listed

Sponsors

Dr RajimunnisaBegam Shaik
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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. Timepoint: Baseline,4 weeks, and 8 weeks

Secondary

MeasureTime frame
To evaluate the add-on effect of Mahakalyanaka vati capsules on WHOQOL-BREF Timepoint: On baseline 0th day and 60th day

Countries

India

Contacts

Public ContactDr RajimunnisaBegam Shaik

KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya and Medical Research Centre, Belagavi

dr.razia.sk@gmail.com7019454157

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026