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CTRI Number  CTRI/2024/07/070011 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
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 ahiphena vyasana (opium addiction) 
Scientific Title of Study   An exploratory single-arm study on kaktinduk vati and mansayadi choorna in the management of ahiphena 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 Mohit Saini 
Designation  MD Scholar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
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 
Phone  9571818147  
Fax    
Email  sainim8854@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ritu Kapoor 
Designation  Associate professor 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
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 
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 Rajasthan 
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 
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 
Address  PG Department of Agad Tantra Post Graduate Institute of Ayurved jodhpur 342037 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohit Saini  Post Graduate Institute of Ayurved Jodhpur  PG department of Agad tantra Post graduate institute of ayurved jodhpur 342037
Jodhpur
RAJASTHAN 		 9571818147

sainim8854@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F112||Opioid dependence. Ayurveda Condition: MANOVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kaktinduk vati, Reference: Rastantrasaar & Siddhaprayog Samgraha.Vol-2nd Edition 18th, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -
(2) Medicine Name: Mansayadi Choorna, Reference: Siddha Yoga Samgraha by Vaidya Yadav Ji Trikam Ji, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed Patient with mild to moderate withdrawal symptoms with COWS score of 5-12 & 13-24
Age between 16-60 years.
Clinical manifestations of Opium withdrawal patients include Restlessness, Anxiety, Muscle aches, Increased lacrimation, Insomnia, Runny nose, Sweating, and Yawning.
Late symptoms include Abdominal cramps, Nausea, Vomiting, diarrhoea, Dilated pupils, Gooseflesh Skin etc. which will be presented at that time.
Patient willing to give consent for clinical trial.
Patient of either sex.
 
 
ExclusionCriteria 
Details  Opium-addicted patients suffering from major systemic illnesses like
Myocardial infarction,
Ischemic heart disease,
Hypertension,
Tuberculosis,
Bronchial asthma,
HIV-AIDS,
Cancer,
Major respiratory disease,
Liver failure,
Renal failure, and Renal toxicity.
 
 
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
 		 28 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve the Quality of Life
 		 28 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)   02/08/2024 
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 kaktinduk vati and mansayadi choora 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 4gm and 2 tablets orally twice a day. Total duration of the treatment is 28 days followed up once in a week regularly.

 
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