| CTRI Number |
CTRI/2024/06/069625 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The Effect of Okra on Endurance in Recreational Runners |
|
Scientific Title of Study
|
A Randomised, Double-Blind, Placebo-controlled, study to determine the effect of Abelmoschus esculentus (Okra) extract on endurance in recreational runners. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-01OKR0524H2-WES21 Version 1 dated 06 May 2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd, Desom P.O, Aluva Ernakulam
Ernakulam
KERALA
683102
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd, Desom P.O, Aluva Ernakulam
KERALA
683102
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Sooraj Rajasekharan Kartha |
| Designation |
Scientist- Clinical Research |
| Affiliation |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd, Desom P.O, Aluva Ernakulam
Ernakulam
KERALA
683102
India |
| Phone |
9847670997 |
| Fax |
|
| Email |
sooraj@arjunanatural.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Arjuna Natural Pvt Ltd, Desom P.O, Aluva Ernakulam 683102 |
|
Primary Sponsor
Modification(s)
|
| Name |
Arjuna Natural Pvt Ltd |
| Address |
Arjuna Natural Pvt Ltd, Desom P.O, Aluva Ernakulam 683102 |
| Type of Sponsor |
Other [Nutraceutical] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhavanam Kishore |
Amor Hospitals |
Department of ortho, consultant room, Near Balanagar Metro Station, Y Junction,Kukatpally, Hyderabad -500072
Hyderabad
TELANGANA |
7569707316
dr.kishore.amorhospitals@gmail.com |
| DrAshok Kumar Patnala |
Medi Links Polyclinic |
Department of Orthopedics, room 2, Opp hero showroom, Dondaparthy ,530016
Visakhapatnam
ANDHRA PRADESH |
9849123602
drashokp.research@gmail.com |
| Dr Rakesh Komuravelli |
Srikara Hospitals |
Department of ortho,
consultant room ground
floor, Street no.7, Near RTC X Road,
Beside Nabard, Musheerabad, Zamistanpur, kavdiguda,
Hyderabad-500020.
Hyderabad
TELANGANA |
9866113630
dr.rakeshkomuravelli@gmail.com |
| Dr Madhu Geddam |
Srikara Hospitals, |
Department of ortho,
consultant room ground
floor, #222&223, Phase II, Mythri Nagar, Madinaguda,
Miyapur, Hyderabad-500049.
Hyderabad
TELANGANA |
8328671684
drmadhu.srikarahospitals@gmail.com |
| Dr Vineet Kumar Shukla |
Tender Palm Hospital |
Dr. Vineet Kumar Shukla OPD, 4th floor, Department of General Medicine, Sec-7, Amar Shaheed Path, Gomtinagar Extension, Lucknow-226010.
Lucknow
UTTAR PRADESH |
79053 04034
vineetshukla38@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee Narayana Diagnostics |
Approved |
| Institutional Etchics Committee Medigene Multi Speciality Hospital Private Limited |
Approved |
| Srikara Hospital Ethics Committee |
Approved |
| Srikara Hospital Ethics Committee |
Approved |
| Srikara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Recreational runners |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
IP1 - Okra extract + Placebo |
Abelmoschus Esculentus extract (okra) 500 mg + Placebo ( Wheat powder 100%) 500mg for 30 days. |
| Intervention |
IP2 - Okra extract |
Abelmoschus Esculentus extract (okra) 1000 mg for 30 days |
| Comparator Agent |
IP3 - Placebo |
Wheat powder 100% 1000mg for 30 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Males and Females 25 to 40 years of age (1:1 ratio)
Body Mass Index between from 18.5 to 24.9 kg/m2
Being recreationally active – Habitual running for 30 min for at least 3 days in a week for the past 3 months.
IPAQ vigorous activity not less than 720 MET minutes per week.
Normotensive (seated, resting systolic blood pressure less than 140 mm Hg and diastolic blood
pressure less than 90 mm Hg. Normal seated, resting heart rate (less than 90 beats per minute).
Subjects who are willing to refrain from using protein, vitamin, mineral and herbal supplements for the study period.
Ability to follow all instructions in the study protocol and be willing to give written
informed consent. |
|
| ExclusionCriteria |
| Details |
COVID positive in the past 6 months.
Received any vaccinations in the past 6 months.
Current use of prescription or over-the-counter medications or unwillingness or inability to discontinue use of these medications at least 4 weeks before beginning the study.
Cardiovascular complications.
Use of protein, vitamin, mineral, and herbal supplements 1 week before the study.
Alcoholic (greater than 2 pegs(60ml)per day) and smoking (has not stopped within 3 months of the study)
Medical problems that would be a direct physical limitation.
Current treatment for depression, alcohol or substance abuse, or psychosis
Women of childbearing age intending for pregnancy or are pregnant, breastfeeding, or willing to practice contraception.
Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study.
Subjects who are unwilling to abstain from consuming okra and any other dietary supplements and to maintain their normal training and dietary habits.
Subjects who participated in a clinical trial for the past 3 months.
Unwilling to provide written informed consent. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in the total distance covered on treadmill in the 15 min timed test. |
Day4 and Day34 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in peak power output in the vertical jump test |
Day4 & Day34. |
| Mean change in time to exhaustion in the Barbell lift & hold test |
Day4 & Day34. |
| Mean change in Borg 6-20 RPE scale |
Day4 & Day34 |
| Mean change in the mean score of FSS, & VAS-F |
Day4 & Day34 |
| Mean change in biomarkers |
from D4 to D34 |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
09/07/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endurance is the ability to sustain prolonged
physical or mental effort. It is a critical component of athletic performance,
particularly in sports and activities that require sustained energy output over
extended periods, such as long-distance running, cycling, and swimming. This study focuses on the effect of okra extract on endurance in recreational runners. Recreational endurance runners are individuals
who engage in long-distance running as a form of exercise, hobby, or
competitive sport, but not at a professional or elite level. In preclinical studies okra had demonstrated anti-fatigue activity. Despite the abundance of
anecdotal evidence and preclinical studies suggesting these benefits, no
clinical trials have yet been conducted to confirm these effects in human
subjects. By investigating okra’s impact on endurance and recovery, this trial
aims to provide scientifically rigorous data that could validate its use as a
natural ergogenic aid. The findings may offer a novel nutritional strategy to
improve performance and well-being among recreational endurance runners. |