| CTRI Number |
CTRI/2023/02/050153 [Registered on: 28/02/2023] Trial Registered Prospectively |
| Last Modified On: |
23/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Investigate the reduction of craving in patients admitted for the management of alcohol addiction |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SK Manimalar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 20 21 Department of Noi Naadal National Institute of Siddha
Tambaram Sanatorium
Chennai
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8939215834 |
| Fax |
|
| Email |
malarsiddha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GJ Christian |
| Designation |
professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noinaadal
National Institute of Siddha
Tambaram Sanatorium
Chennai
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SK Manimalar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room.NO.20 21
DEpartment of Noinaadal
National Institute of Siddha
Tambaram Sanatorium
Chennai
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8939215834 |
| Fax |
|
| Email |
malarsiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 20 21
department of Noi naadal
National Institute of siddha
Tambaram sanatorium
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SK Manimalar |
Ayothidoss Pandithar Hospital |
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU |
8939215834
malarsiddha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H||Substance Abuse Treatment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Internal Medicine |
Agathi Ilai Juice 60ml bd af 48 days
Kotthamalli Kudineer 300ml bd af 48 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate
Other Narcotic drug users
Psychiatric disorders
CNS disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Craving in patients in Stage III of Alcoholism will be assessed before and after the intervention by using AUDIT and ACQ Scoring |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
48 Days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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.
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