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CTRI Number  CTRI/2022/09/045723 [Registered on: 21/09/2022] Trial Registered Prospectively
Last Modified On: 10/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study on herbal neutraceuticals in stress management 
Scientific Title of Study   Clinical trial to evaluate the efficacy of herbal Neutraceutical(ADAPTOGEN) WLTH calm ease in stress management 
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 and HOD, Department of Kayachikitsa 
Affiliation  MVR Ayurveda medical college 
Address  Department of Kayachikitsa, MVR Ayurveda medical college, Parassinikkadavu
MVR 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 and HOD, Department of Kayachikitsa 
Affiliation  MVR Ayurveda medical college 
Address  Department of Kayachikitsa, MVR Ayurveda medical college, Parassinikkadavu
MVR 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 and HOD, Department of Kayachikitsa 
Affiliation  MVR Ayurveda medical college 
Address  Department of Kayachikitsa, MVR Ayurveda medical college, Parassinikkadavu
MVR 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 and hospital 
 
Primary Sponsor  
Name  MVR Ayurveda medical college and hospital 
Address  Parassinikkadavu, Kannur 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Centre for Quality and Food safety  Centre for Quality and Food safety, 99 C, East of Kailash, New Delhi, 1100065 
WLTH Ventures LLP  WLTH Ventures LLP, SCF-620, Motor market, Sector 13, Chandigarh-160101, Punjab 
 
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  Room No 10, KC Unit-2, OPD Building,MVR Ayurveda medical college, 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 Institutioinal ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: UNMADA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: WLTH calm ease, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3.5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -
2Comparator Arm (Non Ayurveda)-PlaceboRoute: Oral, Dosage form: Powder, Dose: 3.5gm, Frequency: OD, Duration: 14 days, Anupana: Lukewarm water
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Both the sexes, which fulfills the diagnostic criteria 
 
ExclusionCriteria 
Details  Hypertension, Cardiac disorders, IBD, Herb sensitivity, endocrine disorders, pregnancy and lactation etc 
 
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   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Blood cortisole  before treatment, after 14 days; and followup on 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
Hamilton Anxiety Rating scale  before treatment, after 14 days; and followup on 28th 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)   23/09/2022 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 23-09-2023 and end date provided 23-09-2026?
    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  

It is a randomized participant blinded, comparative placebo controlled trial, to study the efficacy of neutraceuticals in stress management. The trial agent will be given in a dose of 3.5 gm with lukewarm water for 14 days. This will be compared with placebo group. Cortisole level and Hamilton anxiety scoring will be evaluated on before and after 14 days. Followup measurements will be taken in 28th day.

 
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