| CTRI Number |
CTRI/2019/12/022224 [Registered on: 03/12/2019] Trial Registered Prospectively |
| Last Modified On: |
26/12/2019 |
| 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 know effects of ashwagandha in exercise performance |
|
Scientific Title of Study
|
A Randomized, Double-blind, Placebo-controlled, Parallel group, Three-arm Study to Evaluate the Efficacy and Safety of Ashwagandha Root Extract Capsules on Improving Exercise Performance and Cardiorespiratory Endurance in Conjunction with Exercise Training in Healthy Adult Subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prakash Kurmi |
| Designation |
Consulting physician |
| Affiliation |
Consulting physician |
| Address |
Clinical Trial Department, 3rd Floor,
Under Jashoda Nagar Flyover,
Near Himapark Society Vibha-2, Jashoda Nagar, Ahmedabad, Gujarat- 382445- India.
Ahmadabad
GUJARAT
3800058
India |
| Phone |
91-9825047692 |
| Fax |
|
| Email |
dr_prakashkurmi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Yadvendra Singh |
| Designation |
Project Manager |
| Affiliation |
Cliantha Research |
| Address |
Karmic Lifesciences LLP
(Operating as Cliantha Research)
Unit No. 02, Ground Floor, Reliable Plaza,
Plot No. K10,
Thane-Belapur Road, Airoli,
Thane
MAHARASHTRA
400708
India |
| Phone |
91-22-6143-8600 |
| Fax |
|
| Email |
yraghuvanshi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Yadvendra Singh |
| Designation |
Project Manager |
| Affiliation |
Cliantha Research |
| Address |
Karmic Lifesciences LLP
(Operating as Cliantha Research)
Unit No. 02, Ground Floor, Reliable Plaza,
Plot No. K10,
Thane-Belapur Road, Airoli,
Thane
MAHARASHTRA
400708
India |
| Phone |
91-22-6143-8600 |
| Fax |
|
| Email |
yraghuvanshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Ltd
Unit 703, 704, 7th Floor, Hubtown Solaris,
N.S. Phadke Marg, Andheri (East),
Mumbai – 400069 |
| Laila Nutraceuticals
40-15-14, Brindavan Colony, Vijayawada-520010, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Inventia Healthcare Ltd |
| Address |
Unit 703, 704, 7th Floor, Hubtown Solaris,
N.S. Phadke Marg, Andheri (East),
Mumbai – 400069 |
| Type of Sponsor |
Other [HealthCare LTD] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Laila Nutraceuticals |
40-15-14, Brindavan Colony,
Vijayawada-520010, Andhra Pradesh,
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakash kurmi |
Shivam Hospital |
Clinical Trial Department, 3rd Floor,
Under Jashoda Nagar Flyover,
Near Himapark Society Vibha-2, Jashoda Nagar, Ahmedabad, Gujarat- 382445- India.
Ahmadabad
GUJARAT |
91-9825047692
dr_prakashkurmi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shivam Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Exercise Performance and Cardio-respiratory Endurance. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha Root Extract Capsule 100 mg |
Ashwagandha Root Extract Capsule 100 mg, once daily, oral for 56 days |
| Intervention |
Ashwagandha Root Extract Capsule 150 mg |
Ashwagandha Root Extract Capsule 150 mg, once daily, oral for 56 days |
| Comparator Agent |
Placebo |
Placebo, once daily, oral for 56 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Healthy adult male subjects aged between 21-45 years with a BMI between 22 and 29 kg/m2.
2. Subjects willing to be acquainted with the gym equipment for 1-2 weeks before enrolling in
the study.
3. Ability to understand the risks/benefits of the protocol.
4. Subjects considered generally healthy as per health history and routine clinical investigations.
5. Subjects agree to perform physical activities as stated in the protocol in the presence of physical
trainer.
6. Subjects should provide written informed consent and agree to be available for regular followup
throughout the study duration.
7. Subjects agree not to start any new therapies or energy boosting supplements or protein
supplements or health drinks during the study.
8. Agree to follow the dietary instructions as advised by the nutritionist during the counselling
session. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs. 2. Concomitant administration or history of consumption within seven (7) days prior to the screening of herbal/nutraceutical/ vitamin-minerals supplements. 3. Concomitant use of any supplement including protein/amino acids/creatine/any other product used for muscle growth/recovery/ stamina and cardiorespiratory endurance. 4. Subjects using any other therapies that would affect body composition other than those revealed during the recruitment process. 5. History or presence of any cardiovascular or bronchial / airway disease including but not limited to hypertension, myocardial infarction, coronary artery disease, cardiac failure, angina, arrhythmia, bronchial asthma. 6. Clinically significant 12- Lead ECG. 7. History or presence of any chronic systemic disorder including but not limited to endocrine, neurological, hepatic or renal disease, diabetes mellitus, stroke.
8. Subjects having clinically significant abnormal findings as per investigator’s discretion in the hematological and biochemical laboratory tests. 9. Human immunodeficiency virus (HIV) positive subjects.10. Subjects who consume alcohol or smoke. 11. Subjects having a history or presence of psychiatric disorder. 12. Subjects with a history of any major surgical procedure within the last 6 months. 13. The subjects who have participated in a clinical study within the last 90 days before recruitment.14. Institutionalized subjects.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Muscle strength (measured by leg extension and bench press through one repetition maximum (1 RM))
Muscle endurance (measured by leg extension and bench press through 1 RM)
Cardiorespiratory endurance exercise by treadmill (maximal oxygen uptake (VO2 max)) |
Change from the baseline to the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body composition by dual-energy X-ray absorptiometry (DEXA) scan (to evaluate the increase in lean muscle mass/ reduction in fat component)
Serum testosterone level (free and total)
Serum cortisol level
Muscle damage markers in serum (creatine phosphokinase (CK) and lactate dehydrogenase (LDH) level) |
Change from the baseline to the end of the study |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2019 |
| 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="8"
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)?
|
|
Brief Summary
|
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Three-Arm Study to Evaluate the Efficacy and Safety of Ashwagandha Root Extract Capsules on Improving Exercise Performance and Cardiorespiratory Endurance in Conjunction with Exercise Training in Healthy Adult Subjects.
Study Type: Interventional
Objective: Primary Objective: To evaluate the superiority of Ashwagandha root extract capsules in improving muscle strength & endurance and cardiorespiratory endurance in healthy adult male subjects undergoing exercise training in comparison to placebo. Secondary Objectives: To compare the efficacy of Ashwagandha root extract capsule low dose vs. Ashwagandha root extract capsule high dose in improving muscle strength & endurance and cardiorespiratory endurance in healthy adult male subjects undergoing exercise training. To assess the safety and tolerability of the study supplements. To assess the effect on lean body mass of Ashwagandha root extract capsules in comparison with placebo. To evaluate the changes in hormonal profiles in Ashwagandha root extract capsules supplemented subjects in comparison with placebo. To evaluate recovery from exercise-induced muscle damage in Ashwagandha root extract capsules supplemented subjects, in comparison with placebo.
Design: A randomized, double-blind, placebo-controlled, parallel group, three-arm study.
Efficacy Endpoints: Primary Endpoints: Change from the baseline to the end of the study in: Muscle strength (measured by leg extension and bench press through one repetition maximum (1 RM)) Muscle endurance (measured by leg extension and bench press through 1 RM) Cardiorespiratory endurance exercise by treadmill (maximal oxygen uptake (VO2 max)) Secondary Endpoints: Change from the baseline to the end of the study in: Body composition by dual-energy X-ray absorptiometry (DEXA) scan (to evaluate the increase in lean muscle mass/ reduction in fat component) Serum testosterone level (free and total) Serum cortisol level Muscle damage markers in serum (creatine phosphokinase (CK) and lactate dehydrogenase (LDH) level) Safety Endpoints: ï‚· Adverse events (AEs), frequency and severity Number of subjects who discontinue study due to adverse events
Number of subjects: A total of 120 healthy adult male subjects (i.e. Arm 1: 40, Arm 2: 40, Arm 3: 40) need to be enrolled in the study to achieve 80% power considering 15% dropout rate.
|