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CTRI Number  CTRI/2023/11/059608 [Registered on: 07/11/2023] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Stamina and Endurance of Madhuka flower on Sportspersons and Healthy Volunteers  
Scientific Title of Study   Pharmaco-therapeutic Evaluation of Balya Action of Madhuka Pushpa on Sportspersons and Healthy Volunteers  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aanchal Mittal  
Designation  MD Scholar 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital  
Address  Department of Dravyaguna Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  9958979602  
Fax    
Email  mittalaanchal3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Sharma  
Designation  Associate Professor and Head of Department  
Affiliation  Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi  
Address  Department of Dravyaguna Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  9868092250  
Fax    
Email  rajsakshi.sharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Sharma  
Designation  Associate Professor and Head of Department  
Affiliation  Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi  
Address  Department of Dravyaguna Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  9868092250  
Fax    
Email  rajsakshi.sharma@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College and hospital Opd no 18 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College  
Address  Ayurvedic and Unani Tibbia College and hospital Karol Bagh New Delhi 110005 
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 Aanchal Mittal  Ayurvedic and Unani Tibbia College and Hospital   OPD 18 PG Department of Dravyaguna
Central
DELHI 
9958979602

mittalaanchal3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee AUTCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Subjects  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Madhuka, Reference: Dhanwantari nighantu, Route: Oral, Dosage Form: Khanda /Granules, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -
Intervention  Administration of Madhuka Pushpa granules   3 grams BD 
Comparator Agent  Placebo granules   3 grams BD 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Physically and mentally healthy sportspersons and healthy volunteers who fit in the Par-Q Test (Physical Activity Readiness Questionnaire)
Healthy sportspersons and healthy volunteers irrespective of sex, religion, education, occupation etc and aged between 18 or 30 years will be selected for the study.
Sportspersons involved in outdoor games only, specifically athletics or swimming. 
 
ExclusionCriteria 
Details  The sportspersons and healthy volunteers who are taking treatment for any major disorders or with physical disability.
Subjects on systemic or oral steroids or with alcohol or drug dependency.
Subjects who have participated in any clinical trial in past 6 months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The expected primary end point is that Madhuka (Madhuca indica J.F. Gmel) is effective in Enhancement of Stamina and Endurance in Sportspersons and healthy volunteers (Balya) which will be assessed through subjective and objective parameters and the Five point investigators global assessment scale (very much improved, much improved, improved, mildly improved, worse) will be used for efficacy.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
The expected secondary end point is the assessment of pharmacognostical and phytochemical properties of the drug which will be done through GMP certified labs.  3 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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/ Phase 3 
Date of First Enrollment (India)   01/12/2023 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    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 [mittalaanchal3@gmail.com].

  6. For how long will this data be available start date provided 17-01-2025 and end date provided 17-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Healthy living with full strength and vigor is a dream of every individual living this earth. Hence, he always revised and defined the concept of complete health to suit the needs of the time. But the definition of Acharya Sushruta defined in Sutra Sthana 15th chapter 41st quotation, that has considered proper functioning of every component that have their own influence in maintaining the quality of life or living. Ayurveda being one of the leading systems of Alternative Medicines cannot be away from new inventions to enter into new fields. The sports Medicine is one of such fields where it has to show its power of cure and power of preventing diseases.

Ayureda, the science of healing has stood the tides of time and is now again the popularity which it had lost in the middle for many reasons. The sources of medicines used in Ayurveda are usually from the natural ones which are either animal, mineral and the most important one is the plants.

Among the three sources the plant origin drugs form the majority of drugs mentioned in the materia medica. Today, the knowledge of drugs with respect to identification, formulation and use has gone far beyond those mentioned in the classical texts. But still there are many instances where there is necessary to reprove the claims that are done in the classical literatures. Hence, research for the Balya activity of drugs among the sportspersons and healthy volunteers to increase their stamina and endurance and to establish the claims of classical literature is of utmost importance.

Balya Karma as described in Ayurveda is a complex one, which unfolds many activities of the balya drugs on deep analysis. Hence, a comprehensive protocol involving many testing mechanisms is necessary for the evaluation and ascertainment of such an activity of Ayurveda.

Ayurveda holds the concept of Brimhana and Balya for overall growth of the body and potentiating the strength, energy and endurance in the healthy individuals. Hence, the drugs that are useful in enhancing the physical strength and sports performance of sportspersons and healthy volunteers are to be looked for. In other words that which is favourable and lead to the increase of ‘Bala’ is considered as ‘Balya’. Hence it is quite necessary to understand the concept of Bala as per Ayurveda.

 
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