| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Subjects |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mittalaanchal3@gmail.com].
- 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.
- 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. |