| CTRI Number |
CTRI/2025/03/083139 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| 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 trial on muscle endurance in healthy male volunteers |
|
Scientific Title of Study
|
A prospective, Randomized, double blind, placeb controlled Clinical Trial to valuate the efficacy and safety of Ashwagandha product in the improvement of Muscle strength and endurance in healthy male subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/ASH/MS/2024Version1.0 Date: 30th October 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| INGEX BOTANICALS PRIVATE LIMITED
No.508, Medini, 60 ft road
F Block, Sahakaranagar, Bengaluru-560092,
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Ingex Botanicals Private Limited |
| Address |
No.508, Medini, 60 ft road
F Block, Sahakaranagar, Bengaluru-560092,
Karnataka, India. |
| Type of Sponsor |
Other [ [Nutraceutical supplement company]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bio Actives Japan KK |
4-1-1, BAJ Bldg., Minami-Nagasaki, Toshima-Ku, Tokyo, JAPAN -171-0052 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| S Amarnath Reddy |
Sri Venkateshwara Hospital, |
Sky Heights, Site No 1, Sarjapura–Attible Road,
Bengalore – 562107, Karnataka.
Bangalore
KARNATAKA |
9003154951
sudhaamarnathreddy1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male subjects who are gym going |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Starch |
Each capsule containing
Starch 300 mg to be
taken two capsules daily
orally in the morning
after breakfast and night
after dinner: Duration 60 days |
| Intervention |
Ashwagandha
|
Each capsule containing
Ashwagandha extract 300 mg
to be taken two capsules
daily orally in the morning
after breakfast and night after dinner: Duration 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Male volunteers between the age group of 25-45 years.
2. Subjects who are familiar with weight training and had at least 3 months of
experience in the gym (defined as 4 times per week for minimum of 3 to 4 hours
per week).
3. Subjects who are willing and able to understand and follow the protocol and
provide informed consent.
4. Agree not to use any medication (prescription and over the counter), including
vitamins and minerals, and any alternative medications during the course of this
study.
5. Subjects whose blood chemistries are within a normal range or not
considered clinically significant if outside the normal range |
|
| ExclusionCriteria |
| Details |
1.Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological)
2. Patients with pre-existing severe systemic disease necessitating long-term medication.
3. Subjects suffering from any serious medical or surgical illness.
4. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
5. Any neurological (congenital or acquired), musculoskeletal, joint health conditions, psychological, vascular or systemic disorder which could affect any of the efficacy assessments.
6. Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate), ECG hematology, serum chemistry.
7. More than 4 short courses of oral corticosteroids within the year preceding the screening visit, or any oral corticosteroids in the preceding 4 weeks.
8. Use of Astemizole, Nedocromil, Cromolyn, long acting beta agonists, Ketotifen, Theophylline or testosterone within 4 weeks before.
9. Participation in the current or previous clinical trial with any approved investigational products during the past 1 month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Endpoints:
1.change from baseline muscle and connective tissue strength,
assessed by one-repetition maximum (1-RM) bench and leg presses
2.Handgrip strength (Dynamometer)
3.Cable pull-down repetitions and pounds
4.Time to exhaustion on a treadmill
5.Mid-upper arm circumference (MUAC)
6.The change from baseline testosterone assessed by free and total testosterone.
7.Improvement in Muscle Strength, stamina and sustained energy level and the
safety of Ashwagandha extract product and consumer acceptance through Self
Assessment and Feedback questionnaires through Global Physical Activity
Questionnaires |
Day 0, Day 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The improvement in Cortisol cycle from baseline is assessed by evaluating
Cortisol value
2.Improvement in muscle recovery measured through Biomarkers LDH (Serum
lactate de-hydrogenase), CK (Creatine Kinase), TNF alpha, Glutathione
(GSH) & hs-CRP
3.Change in Serum Collagenase level
4.Change in Serum immune marker levels |
Day 0 & Day 60. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| Date of Study Completion (India) |
26/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Ashwagandha contains a variety of bioactive compounds with significant therapeutic potential. Ashwagandha (Withania somnifera) is a powerhouse of bioactive compounds, each contributing to its extensive therapeutic potential. Among these, alkaloids such as withanine and somniferine are celebrated for their antioxidant, anti-inflammatory, and analgesic effects, offering diverse physiological benefits by reducing oxidative stress, modulating inflammatory pathways, and alleviating pain. The glycosides in Ashwagandha are represented by withanolides, a unique class of steroidal lactones. These compounds exhibit adaptogenic, anti-inflammatory, and anti-stress properties, helping the body manage stress, balance cortisol levels, and improve mental well being. Similarly, flavonoids, abundant in various plants, provide potent antioxidant and anti inflammatory effects, contributing to cardiovascular health by combating oxidative stress and improving vascular function. Saponins, another vital component, are known for their immune modulating and antioxidant properties, enhancing the body’s defense mechanisms while protecting cells from free radical damage. |