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CTRI Number  CTRI/2022/09/045548 [Registered on: 15/09/2022] Trial Registered Prospectively
Last Modified On: 06/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on efficacy of herbal drugs in reducing viral load in HIV/AIDS patients 
Scientific Title of Study   Clinical trial to evaluate the therapeutic efficacy of two herbal drugs STERISWAS-G1 and STERICHARM-HSA in reducing the viral load among HIV/AIDS patients, and also to document file improvement in the conditions of HIV/AIDS patients opportunistic coinfections 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shyam Prasad M 
Designation  Professor, Kayachikitsa-Head of Department 
Affiliation  MVR Ayurveda medical college 
Address  Department of Kayachikitsa MVR Ayurveda medical college(old name-Parassinikkadavu Ayurveda medical college), Parassinikkadavu, Kannur

Kannur
KERALA
670563
India 
Phone  9496192409  
Fax    
Email  getshyampm@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shyam Prasad M 
Designation  Professor, Kayachikitsa-Head of Department 
Affiliation  MVR Ayurveda medical college 
Address  Department of Kayachikitsa MVR Ayurveda medical college(old name-Parassinikkadavu Ayurveda medical college), Parassinikkadavu, Kannur


KERALA
670563
India 
Phone  9496192409  
Fax    
Email  getshyampm@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shyam Prasad M 
Designation  Professor, Kayachikitsa-Head of Department 
Affiliation  MVR Ayurveda medical college 
Address  Department of Kayachikitsa MVR Ayurveda medical college(old name-Parassinikkadavu Ayurveda medical college), Parassinikkadavu, Kannur


KERALA
670563
India 
Phone  9496192409  
Fax    
Email  getshyampm@yahoo.co.in  
 
Source of Monetary or Material Support  
MVR Ayurveda medical college  
 
Primary Sponsor  
Name  MVR Ayurveda medical college 
Address  Parassinikkadavu, Kannur, Kerala 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Stecure Health Solutions Pvt Ltd  Stecure Health Solutions Pvt Ltd, 24, 904/5, Areeckal tower, East nagarAngamaly, Erunakulam, Kerala, 683572 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shyam Prasad M  MVR Ayurveda Medical college hospital  OPD Building, Kayachikitsa unit 2, Room Number 10, Parassinikkadavu, Kannur
Kannur
KERALA 		 9496192409

getshyampm@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MVR Ayurveda medical college Parassinikadavu Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B20||Human immunodeficiency virus [HIV]disease. Ayurveda Condition: RAJAYAKSHMA, (2) ICD-10 Condition:B20||Human immunodeficiency virus [HIV]disease. Ayurveda Condition: RAJAYAKSHMA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Ashtanga hridaya, Procedure details: The medicine in thick Kashaya form will be externally applied to whole body )
(1) Medicine Name: STERICHARM-HSA, Reference: Ayurveda pharmacopia of India , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 10(ml), Frequency: od, Duration: 1 Months
2Intervention ArmProcedure-kavalaH, कवलः (Procedure Reference: Ashtanga hridaya, Procedure details: the medicine in kashaya form (5ml) will be given for gargling, for 5 minutes, twice a day. )
(1) Medicine Name: STERISWAS-G1, Reference: Ayurveda pharmacopia of India , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 5(ml), Frequency: bd, Duration: 1 Months
3Comparator Arm (Non Ayurveda)-ANTI RETROVIRAL THERAPYTHE ONGOING Anti retroviral therapy(ART) WILL BE COMPARED WITH INTERVENTION ARM
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  those with ART regime and not under life threatening conditions  
 
ExclusionCriteria 
Details  those with serious systemic illness  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction in viral load  Viral load will be evaluated before the treatment, after 15 days and after 30 days of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvements in associated opportunistic confection and symptoms.Viral load measurement will be taken after 10days from stopping the Ayurveda regime (40th day)  Will be assessed before the treatment,after 15 days and 30 days of treatment. A follow-up evaluation will be done on 40th day. 
 
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 2 
Date of First Enrollment (India)   16/09/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  results will be shared

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [getshyampm@yahoo.co.in].

  6. For how long will this data be available start date provided 16-08-2023 and end date provided 15-08-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   this is a   randomized open ended comparative clinical trial, to evaluate the therapeutic efficacy of stericharm-HSA (external application) and steriswas-G1(for gargling). Both the drugs will be given to trial group, those with ART regime. This will be compared with the     control group under only ART. Viral load will be evaluated at before treatment, after 15 days and after 30 days of trial. Follow up evaluation will be done on 40th day.
 
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