| CTRI Number |
CTRI/2024/07/070196 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of ahiphen vyasana(opium addiction)
|
|
Scientific Title of Study
|
A clinical efficacy of sameergaj kesari ras, medhya rasayan along with cognitive behavioral therapy in the management of ahiphen vyasana (opium addiction) |
| 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 Naresh lohiya |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur |
| Address |
PG Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN India
Jodhpur
RAJASTHAN 342037
India
PG Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN India
Jodhpur
RAJASTHAN 342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9530288882 |
| Fax |
|
| Email |
drnmlohiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu kapoor |
| Designation |
HOD & Associate Professor |
| Affiliation |
Post graduate institute of Ayurved |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Room no 128 PG Department of Agad Tantra Evam Vidhi Vaidyaka Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9529831215 |
| Fax |
|
| Email |
drritukapoor4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Kapoor |
| Designation |
Associate professor |
| Affiliation |
Post Graduate Institute Of Ayurved Jodhpur |
| Address |
PG Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN India
Jodhpur
RAJASTHAN 342037
India
PG Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN India
Jodhpur
RAJASTHAN 342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9529831215 |
| Fax |
|
| Email |
drritukapoor4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute Of Ayurved Jodhpur 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of ayurved, jodhpur, rajasthan |
| Address |
Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Naresh Lohiya |
Post Graduate Institute of Ayurved jodhpur |
PG department of Agad tantra Post graduate institute of ayurved jodhpur 342037 Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9530288882
drnmlohiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Post Graduate Institute of Ayurved Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F112||Opioid dependence. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Samiragaja kesari rasa, Reference: Rasa tantra saar & Siddha prayoga Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Medhya rasayan, Reference: chakradutta samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -madhu & cows ghee), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed Patient moderate sever withdrawal symptoms with COWS score of 24-36.
Age between 16 - 60year.
Clinical manifestation of opium withdrawal patient including agitation, anxiety, muscles aches, increased tearing, insomnia, runny nose, sweating, yawning and late symptoms include: abdominal cramping, nausea, vomiting, diarrhea, dilated pupils, goose bumps etc which will be presented at that time.
Patient willing to give consent for clinical trial.
Patients of either sex. |
|
| ExclusionCriteria |
| Details |
Opium addicted patients who are suffering from major psychiatric disorder.
Opium addicted previously diagnosed patients of major systemic illness like myocardial infarction, Ischemic heart disease, Hypertension, Tuberculosis, Bronchial Asthma, HIV- AIDS, Cancer, Major respiratory disease, liver failure, Renal failure and Renal toxicity etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the COWS score of the patient |
42 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the Quality of Life |
42 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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 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
|
This study is single arm, an open label trial, with single group of 30 patients to assess the efficacy of sameergaj kesari ras (2 tablet B.D.) along with medhya rasayan ( 3 gm B.D. ) with CBT in the management of opium addiction. The primary objective of the study is reducing subjective criteria COWS score. drug will be administered with lukewarm water after meal in the dosage of 2 tablet BD and 3gm BD orally twice a day. Total duration of the treatment is 42 days followed up once in a week regularly. |