| CTRI Number |
CTRI/2023/02/049575 [Registered on: 09/02/2023] 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
|
Study on herbal neutraceuticals in delivering physical energy |
|
Scientific Title of Study
|
A clinical trial to assess the efficacy of herbal neutraceuticals in delivering the Physical Energy |
| 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 |
MVR Ayurveda Medical college, (Parassinikkadavu Ayurveda medical college-old name), 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 |
MVR Ayurveda Medical college, (Parassinikkadavu Ayurveda medical college-old name), 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 |
MVR Ayurveda Medical college, (Parassinikkadavu Ayurveda medical college-old name), 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 |
MVR Ayurveda college, Parassinikkadavu, Kannur |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Centre for Quality and Food safety |
99C, East of Kailash, New Delhi, 1100065 |
| 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 hospital |
Room No-10, Kayachikitsa Unit-2, OPD Building, MVR Ayurveda college, Parassinikkadavu
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy youth individuals who are in activities like hard exercise, sports and games etc |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: WLTH energy, 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: - | | 2 | Comparator Arm (Non Ayurveda) | | - | placebo | Rawa powder, 3.5 gm, OD, for 14 days with luke warm water |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers |
|
| ExclusionCriteria |
| Details |
All diseased individuals |
|
|
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 |
| Creatine kinase |
before trial, 14th day and followup on 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| strength and power test/plyometric evaluation |
before trial, 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)
|
17/02/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 (Others) - via email
- For how long will this data be available start date provided 14-02-2025 and end date provided 17-02-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This is a randamized placebo controlled clinical trial to evaluate the efficacy of herbal neutraceuticals in delivering physical energy and the trial will be carried out in healthy volunteers. The tral drug will be given for 14 days in powder form in a dose of 3.5g with luke warm water. follow up will be done on 28th day. the outcomes measured will be creatine kinase and plyometric evaluation/ strength and power test
|