| CTRI Number |
CTRI/2025/11/098021 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Jatiphaladi Churna Vati And Trailokya Vijaya Vati In Opioid Use Disorders |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Jatiphaladi
Churna Vati And Trailokya Vijaya Vati In Opioid Use Disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Singh Pooja Jairam |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Agadtantra, National Institute of Ayurveda, Jorawar Singh Gate, Amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7507478460 |
| Fax |
|
| Email |
singhpooja1203@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Anita Sharma |
| Designation |
Professor and H.O.D of Agadtantra department |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Agadtantra, 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 |
Singh Pooja Jairam |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Agadtantra, National Institute of Ayurveda, Jorawar Singh Gate, Amer road, Jaipur
RAJASTHAN
302002
India |
| Phone |
7507478460 |
| Fax |
|
| Email |
singhpooja1203@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jorawar Singh Gate, Amer road, Jaipur, Rajasthan 302002, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda, Jaipur |
| Address |
Madhav Vilas Palace, Jorawar Singh Gate, Amer road, Jaipur 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 Singh Pooja Jairam |
OPD no. 25 Agadtantra Department, National Institute of Ayurveda, Jaipur |
Madhav Vilas Palace, Jorawar Singh Gate, Amer road, Jaipur 302002
Jaipur
RAJASTHAN |
7507478460
singhpooja1203@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:F119||Opioid use, unspecified. Ayurveda Condition: MADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatiphaladi Churna Vati, Reference: Sharangdhara Madhyam Khand, 6/72-76 (Churna Prakaran), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koushnajala), Additional Information: Medicine will be given in tapering dose | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trailokya Vijaya Vati, Reference: Rasatarangini 24/ 427-430 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koushnajala), Additional Information: Medicine will be given in tapering dose | | 3 | Intervention Arm | Procedure | - | Sarvanga abhyanga | (Procedure Reference: Ashtanga Hridaya Sutrasthan 2/8, Procedure details: daily massage of entire body with taila)
(1) Medicine Name: Ksheerbala taila, Reference: Sahasrayogam Taila prakaran page no. 110 , Route: Topical, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 21 Days | | 4 | Comparator Arm | Procedure | - | Sarvanga abhyanga | (Procedure Reference: Ashtanga Hridaya Sutrasthan 2/8, Procedure details: Daily massage of entire body with taila)
(1) Medicine Name: Ksheerbala taila, Reference: Sahasrayogam Taila prakaran page no. 110 , Route: Topical, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with COWS score ranging from 5-24
Patients of either sex
Patients willing to give consent for clinical trial
Age between 18-60 years |
|
| ExclusionCriteria |
| Details |
Patients having addiction other than Opium
Patients with any type of psychiatric disorders, neurological disorders like Alzheimer’s disease, Parkinsonism, any type of Venereal diseases, any major systemic diseases like Carcinoma, Heart diseases, Hepatic and Renal failure, DM, unmanageable hypertension etc.
Patients who are receiving any contemporary de addiction treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess changes in scores of COWS – Clinical Opiate Withdrawal Scale |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess safety and efficacy of both drugs using Liver Function Test and Renal Function Test |
21 days |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
02/03/2026 |
| 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="20" |
|
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
|
Opioid use disorders is a condition in which a person uses various forms of opium for addiction purpose. Currently Opioid replacement therapy is used with drugs such as methadone which produce some side effects. Hence an ayurvedic alternative is being explored. Trailokya Vijaya Vati has shown significant results in withdrawals produced due to opium. Both Jatiphaladi Churna Vati and Trailokya Vijaya Vati contains Bhanga in 50% quantity as an active ingredient which is useful in withdrawal symptoms. Hence a clinical trial is needed to establish comparison between these drugs
|