| CTRI Number |
CTRI/2025/04/084383 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To understand the safety and effects of Ashwa SR capsules on Muscle Strength in Recreationally Active Healthy Subjects. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Parallel Treatment Clinical Study to Evaluate the Safety and Effects of ProlanzaTM (Ashwa SR) 300 mg Capsules on Muscle Strength in Recreationally Active Healthy Subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| iVRS-CD-24-059,Version 01,Dated:31 Jan 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Girish H Rudrappa |
| Designation |
Principal Investigator |
| Affiliation |
Rajalakshmi Hospital and Research Center |
| Address |
Department of Orthopedics, 3rd Floor, OPD Building, Rajalakshmi Hospital and Research Center, 21/1, Lakshmipura, Main Road, Opp. Lakshmipura Lake, Vidyaranyapura Post
Bangalore
KARNATAKA
560097
India |
| Phone |
9845516613 |
| Fax |
- |
| Email |
girirudra@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Channabasavanna G Halasagi |
| Designation |
Medical Monitor |
| Affiliation |
Invitro Research Solutions Pvt. Ltd. |
| Address |
Clinical Development Department, Medical Monitoring Division, Room No 302, 3rd Floor, No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal,
Bangalore
KARNATAKA
560092
India |
| Phone |
6366947473 |
| Fax |
- |
| Email |
channa@ivrs.org.in |
|
Details of Contact Person
Public Query
|
| Name |
T Vijaya Bhaskar |
| Designation |
Senior Director Clinical Development |
| Affiliation |
Invitro Research Solutions Pvt. Ltd. |
| Address |
Clinical Development Department, Room No. 301, 3rd Floor, No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal,
Bangalore
KARNATAKA
560092
India |
| Phone |
6366575282 |
| Fax |
- |
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| Laila Nutraceuticals,
40-15-14, Brindavan Colony,
Vijayawada – 520 010, Andhra Pradesh, India
Tel 91 8666636666 |
| Nutriventia Limited, Unit 703, 704, 7th Floor,
Solaris One Premises Co-operative Society Limited, N.S. Phadke Marg, Andheri
(East), Mumbai – 400 069, Maharashtra, India
Tel 91 2267163000 |
|
|
Primary Sponsor
|
| Name |
Nutriventia Limited |
| Address |
Unit 703, 704, 7th Floor,
Solaris One Premises Co-operative Society Limited, N.S. Phadke Marg, Andheri
(East), Mumbai – 400 069, Maharashtra, India
Tel 91 2267163000 |
| Type of Sponsor |
Other [Nutraceutical industry] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Laila Nutraceuticals |
40-15-14, Brindavan Colony,
Vijayawada – 520 010, Andhra Pradesh, India
Tel 91 8666636666 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Girish H Rudrappa |
Rajalakshmi Hospital and Research Center |
Department of Orthopedics, 3rd Floor, OPD Building, Rajalakshmi Hospital and Research Center, 21/1, Lakshmi Pura, Main Road, Opp. Lakshmipura Lake, Vidyaranyapura Post, Bengaluru (Bangalore) Urban - 560097
Bangalore
KARNATAKA |
9845516613
-
girirudra@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital InstitutionalEthics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Recreationally active and gym going subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
(Ashwa SR) 300 mg capsules |
1 capsule of ProlanzaTM (Ashwa SR) 300 mg capsules to be orally administered with water once daily after breakfast for duration of 90 Days |
| Comparator Agent |
Placebo Capsules |
1 capsule of placebo to be orally administered with water once daily after breakfast for duration of 90 Days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects aged between 25-50 years (both inclusive) who are recreationally active and gym going subjects who are at the initial stages of their strength training (less than 1 month).
2. Subjects within the BMI range of 25.0 to less than 29.9 kg/m².
3. Healthy subjects as determined by: Medical history, Physical examination, and clinical judgment of the investigator.
4. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy
5. Results of screening procedures and lab investigations are within normal range or considered not clinically significant by the Principal Investigator.
6. Subjects who are not dependent on tobacco products alcohol consumption or any other substance abuse and are agreeing to refrain from alcohol, tobacco products and other substances of abuse during the study.
7. Subjects who agree to refrain from any kind of supplements (protein and metabolism supplements, steroids etc) that enhance muscle strength and performance.
8. Subjects who agree to maintain normal diet without any major amplifications or modifications during the study.
9. Subjects who agree to be consistent with their workout regimen (must attend the gym/fitness session for 5 continuous days of a 7-day week with alternating days of resistance training and aerobic training culminating with 2 days of rest) and willing to include bench press, leg extension and treadmill in their regimen.
10. Subjects who agree to abide by the conditions of the study protocol and are willing to sign the informed consent and comply with study procedure.
|
|
| ExclusionCriteria |
| Details |
1. Subjects younger than 25 years or older than 50 years.
2. Female subjects who are pregnant, breast-feeding or who are planning to become pregnant during the study.
3. Subject with hypersensitivity to any of the ingredients of the study products.
4. Subjects with any significant uncontrolled systemic illness (including but not limited to uncontrolled hypertension, chronic renal disease, chronic liver disease, poorly controlled diabetes mellitus, congestive heart failure, coronary artery disease, STDs, musculoskeletal disorders etc.).
5. Concurrent use of supplements for stress/anxiety/sleep/any other indications, herbal or pharmaceutical preparations.
6. Subjects who are concurrently using medication or steroids to enhance physical performance.
7. Subjects who are on any medication/treatment for infertility/enhancement of
sexual function within 6 months prior to study enrolment.
8. Subjects who are alcohol dependent.
9. Subjects who are inconsistent with their workout regimen.
10. Subjects with a weight loss of more than 5 kg in the previous 3 months,
11. Subjects with any history of drug abuse, smoking cigarettes or consuming any tobacco products or alcohol.
12. Subjects with history of any orthopedic injury or surgery within the previous 6 months,
13. Participation in other clinical studies during the previous 3 months.
14. Difficulty in swallowing and retaining oral formulation.
15. Subjects who are not willing or unable to provide blood samples for study related evaluations.
16. Any condition that in opinion of the Investigator, does not justify the Subjects’ participation in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in muscle strength in 1-RM of bench press load |
baseline to day 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of change between Ashwa SR 300 mg and placebo groups for following parameters:
• Muscle strength from baseline to day 30, and 60 in 1-RM of bench press load.
• VO2 max
• Serum testosterone levels
• Serum creatine kinase levels, Lactate dehydrogenase levels
• Comparison of global assessment of therapy
• Comparison of TEAEs.
• Comparison of General QOL- SF-12
|
baseline to day 91 |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| Date of Study Completion (India) |
28/11/2025 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
Physical fitness, particularly muscle strength and cardiorespiratory endurance, is a key predictor of long-term health, reducing the risk of chronic diseases and premature death. Muscle endurance, which is linked to muscle strength, plays a crucial role in overall fitness and systemic health. VO2 max, a measure of cardiorespiratory endurance, reflects the body’s ability to utilize oxygen during intense exercise. Non-compliance to fitness regimens, particularly resistance training, can hinder progress, but adaptogens like Ashwagandha (Withania somnifera) may improve physical adaptability to exercise. Known for its various health benefits. This herb has been studied as adaptogenic, antioxidant, anticancer, anxiolytic, antidepressant, cardioprotective, thyroid modulating, immunomodulating, antibacterial, antifungal, anti-inflammatory, neuroprotective, cognitive enhancing and hematopoietic properties. Ashwagandha contains a range of bioactives like withanolides, sitoindosides and other alkaloids that are pharmacologically and medicinally important. These protect the cells from oxidative damage and disease.It is also known for its various health benefits. including enhancing energy, endurance, and vitality, Ashwagandha is believed to help improve muscle strength and endurance by reducing stress. The current study aims to assess the safety and effectiveness of Ashwa SR 300 mg capsules in improving muscle strength, endurance, and serum testosterone levels. |