| CTRI Number |
CTRI/2024/12/078687 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Exploring the Efficacy of Ahiphenadi Vati and Sameergaja Kesari Rasa in the Management of Opioid Use Disorder |
|
Scientific Title of Study
|
A Randomized Comparative Trial to Evaluate the Efficacy of Ahiphenadi Vati and Sameergaja Kesari Rasa in Opioid Use Disorder |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRinkesh Vishnoi |
| Designation |
Ph.D. Scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Agad Tantra, National institute of Ayurveda,Jorawar singh gate, Amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8769213229 |
| Fax |
|
| Email |
rinkeshbishnoi29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Anita Sharma |
| Designation |
Professor and HOD |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Agad Tantra, National institute of Ayurveda,Jorawar singh gate, Amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRinkesh Vishnoi |
| Designation |
Ph.D. Scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Agad Tantra, National institute of Ayurveda,Jorawar singh gate, Amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8769213229 |
| Fax |
|
| Email |
rinkeshbishnoi29@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Ayurveda jaipur, Rajasthan India 302002 |
|
|
Primary Sponsor
|
| Name |
National institute of ayurveda |
| Address |
National institute of Ayurveda (Deemed to be university), Jorawer singh gate, Amer road Jaipur, Rajasthan, India 302002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjeev Sharma VC of National institute of Ayurveda |
National institute of Ayurveda |
Room no. 25, Depatment of Agad Tantra, National institute of ayurveda ,Jaipur 302002
Jaipur
RAJASTHAN |
919412635816
nia-rj@nic.in |
| DrRinkesh vishnoi |
National institute of Ayurveda |
National institute of Ayurveda, Jorawar singh gate, amer road jaipur
Jaipur
RAJASTHAN |
8769213229
rinkeshbishnoi29@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:F112||Opioid dependence. Ayurveda Condition: MADATYAYA-ARISHTAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ahiphenadi vati, Reference: Rasatantrasara siddhprayog sangrha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -tepering dase | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sameergaja kesari Rasa, Reference: Rasatantra sara evm siddhprayoga sangra, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -tapering dose |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with early, mild and moderate symptoms with scores of 5-24 after evaluation in COWS scale.
Patients with early, mild and moderate symptoms with scores of 7-21 after evaluation in ISI scale.
Patients of either sex
|
|
| ExclusionCriteria |
| Details |
Patients with severe score above 24 in COWS scale.
Patients with severe score above 21 in ISI scale
Patients with any other type of psychiatric disorder, any type of Venereal diseases, any major systemic diseases like carcinoma, heart diseases, hepatic and renal failure, DM, hypertension etc.
Patients who are receiving any contemporary de addiction treatment.
patients who has with any other substance addiction
|
|
|
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 scores of COWS (Clinical opiate withdrawal scale). |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in score of Insomnia severity index |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
my ph.d. study title is A Randomized Comparative Trial to Evaluate the Efficacy of Ahiphenadi Vati and Sameergaja Kesari Rasa in Opioid Use Disorder, i in role patients after physical examination, and divided into 2 groups, one group will be given ahiphenadi vati and other groups will be given sameergaja kesari rasa |