| CTRI Number |
CTRI/2024/07/070530 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Madatyayahar kashaya and Kharjuradi mantha in Alcohol use disorder |
|
Scientific Title of Study
|
A Randomized comparative clinical study to evaluate the efficacy of Madatyayahar kashaya and Kharjuradi mantha in Madatyaya with special reference to Alcohol use disorder. |
| 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 Anita Sharma |
| Designation |
Head of department , Agad Tantra |
| Affiliation |
National institute of Ayurveda |
| Address |
National institute of Ayurveda, Jorawar Singh gate, jaipur, Rajasthan.
Agad department, Room no. 206
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Sharma |
| Designation |
Head of department , Agad Tantra |
| Affiliation |
National institute of Ayurveda |
| Address |
National institute of Ayurveda, Jorawar Singh gate, jaipur, Rajasthan.
Agad department, room no.206
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharti |
| Designation |
P.G. Scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Agad Tantra, National Institute of Ayurveda, Jorawar Singh gate, Jaipur, Rajasthan.
Agad department, room no. 212
Jaipur
RAJASTHAN
302002
India |
| Phone |
9149739287 |
| Fax |
|
| Email |
dhartikharka@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Ayurveda, Jaipur.Agad department, room no. 208, pincode 302002 |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda |
| Address |
Jorawar Singh gate, Jaipur, Rajasthan, 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 Dharti |
National institute of Ayurveda |
National institute of Ayurveda, opd no.25, de-addiction ward 129,Jorawar Singh gate, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
9149739287
dhartikharka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F109||Alcohol use, unspecified. Ayurveda Condition: MADATYAYAH/PANATYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madatyayahar kashaya, Reference: Sahastrayogam by Dr surendra Sharma and Dr Ramniwas Sharma, page no. 16 under Kashaya prakran, Route: Oral, Dosage Form: Mantha, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kharjuradi mantha, Reference: Charaka Samhita sutra sthana 23rd chapter shlok no. 38, Route: Oral, Dosage Form: Mantha, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical manifestation of alcohol use disorder identified with AUDIT
Patients with AUDIT score more than 8
patients will be selected randomly, irrespective of gender, economical, educational and marital status |
|
| ExclusionCriteria |
| Details |
Patients suffering from any kind of major systemic illness such as Malignancy, Diabetes, Cardiac disease, HIV, Tuberculosis, liver failure, gastro intestinal bleeding, cerebellar degeneration etc.
Patients with severe clinical manifestations of alcohol withdrawal such as Alcohol withdrawal seizures.
Pregnant women and lactating mothers.
Patients who are not considering the proper instructions given to them, highly violent patients, and those suffering from major psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in CIWA-AR (Clinical Institute withdrawal assessment for Alcohol-revised ) |
Changes in CIWA-AR (Clinical Institute withdrawal assessment for Alcohol-revised ) patients will be assessed at 0 week, 2weeks, 4 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Liver function test will be assessed on day 0 & day 30 |
30 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
According to a survey conducted by the Ministry of Social Justice and Empowerment of India, among all other drug use, alcohol plays a major role with the highest prevalence rate. Therefore, specific interventions are needed for alcohol dependence and withdrawal. Drugs for alcohol withdrawal syndrome and alcohol dependence that contain those types of drugs develop dependency and, as a result, cause new addictions to treat existing addictions. Physiological and psychological symptoms develop in case of alcohol withdrawal and Alcohol use disorder. therefore, it is required to develop more effective, safe, cheap and side effect free management to the Madatyaya and Alcohol use disorder. |