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Clinical Trials/CTRI/2023/02/050153
CTRI/2023/02/050153CompletedNot Applicable

A Pilot clinical study to investigate the reduction of craving in patients admitted for the management of alcohol addiction at Ayothidoss Pandithar hospital of National Institute of Siddha

Not provided1 site in 1 country10 target enrollmentStarted: January 3, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Reduction of Craving in patients in Stage III of Alcoholism will be assessed before and after the intervention by using AUDIT and ACQ Scoring

Study Overview

Brief Summary

INTRODUCTION:

Alcoholism is a major health hazard affects 14.6% of Indian population and 5.2% of them needs treatment. Many Alcoholics trying to achieve abstinence experience the craving for Alcohol. DSM - 5 includes the craving as a criterion for an AUD diagnosis. Agathi (Sesbania grandiflora) used in treating "Marundhiduthal" as mentioned in Gunapadam - Mooligai book. Adding to that an article published in 2008 shows positive result in the treatment of Alcohol Withdrawal syndrome in Rats. Kotthamalli Kudineer mentioned in Siddha - Podhu Maruthuvam book(Traditional Knowledge) for treating AUD. in this study, the craving reduction using various scales before and after the intervention with the Sesbania grandiflora leaf juice and kotthamalli kudineer will be assessed.

METHODOLOGY:

The patients will be screened with inclusion and exclusion criteria. After getting consent , screened for Alcohol addiction using AUDIT and assess the severity of craving using ACQ scoring. Enrolled patients will be given interventions for 48 days. Laboratory investigation will be taken before and after the treatment .Prognosis will be documented in the appropriate forms (enclosed with the protocol) . All the data will be entered into the computer and analysed by Sr.Research officer (statistics) for logical errors to avoid any bias. Then final report will be generated.

OUTCOME:

Reduction of craving to Alcohol will be assessed in patients in stage III of Alcoholics before and after the intervention by using AUDIT and ACQ scoring.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Male Female and Transgender Adults Patients in Stage III(Middle Alcoholic Phase) of Alcoholism Increased frequency of Alcohol conception in preceding years Binge drinkers (>4 drinks/occassion) Patients with AUD who willing to participate.

Exclusion Criteria

  • •Patients not willing to participate Other Narcotic drug users Psychiatric disorders CNS disorders.

Outcomes

Primary Outcomes

Reduction of Craving in patients in Stage III of Alcoholism will be assessed before and after the intervention by using AUDIT and ACQ Scoring

Time Frame: 48 Days

Secondary Outcomes

  • The Alcohol withdrawal symptoms after the intervention will be observed.(The blood investigations(CBC,Lipid profile,LFT,RFT) before and after the intervention will be observed.)

Investigators

Sponsor
Not provided

Study Sites (1)

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