Health Condition 1: F102- Alcohol dependence
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Male patients aged 18 to 60 years diagnosed with Alcohol Withdrawal Syndrome. Patients presenting with Trishna and mild to moderate withdrawal symptoms. Medically stable and fit for oral administration of study drug. Willing to participate and provide written informed consent. Not enrolled in any other clinical trial.
Exclusion criteria
Exclusion criteria: Patients with severe withdrawal symptoms such as seizures or delirium tremens. Patients with liver cirrhosis, chronic kidney disease, severe cardiac disorders, uncontrolled diabetes mellitus or hypertension. Patients with psychiatric disorders. Patients with Sjogrens syndrome, diabetes insipidus or SIADH. Known hypersensitivity to study drug. Patients receiving other therapies for alcohol withdrawal outside study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Trishna score assessed using subjective grading scale in patients with Alcohol Withdrawal SyndromeTimepoint: 30 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in Daha burning sensation scoreTimepoint: Day 0 Day 7 Day 15 Day 30;Improvement in Murcha faintness and Aruchi anorexiaTimepoint: Day 0 Day 7 Day 15 Day 30;Reduction in Glani fatigue and Chhardi vomitingTimepoint: Day 0 Day 7 Day 15 Day 30;Improvement in hydration related parameters such as fluid intake urination and drynessTimepoint: Day 0 Day 7 Day 15 Day 30;Assessment of safety tolerability and patient complianceTimepoint: Throughout study period up to Day 30 | — |
Countries
India
Contacts
Yashwant Ayurvedic Medical College P G Training and Research Centre