| CTRI Number |
CTRI/2025/04/085632 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
HSJS-092404 shots study for exercise performance improvement in Gym goers |
|
Scientific Title of Study
|
An Open label, Prospective, Single arm, Clinical Study to Evaluate the Safety and Efficacy of HSJS-092404 in Improving Exercise Performance in Healthy Adult Subjects.” |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshay Dhanda |
| Designation |
Consultant Physician |
| Affiliation |
Xplora Clinical Research Services Pvt Ltd, |
| Address |
Xplora Clinical Research Services Pvt Ltd
Krishna Arcade 3rd Floor #23 5th Main 12th Cross
Wilson Garden Hombegowda Nagar Bangalore
Bangalore
KARNATAKA
560027
India |
| Phone |
9599794872 |
| Fax |
|
| Email |
akshay.dhanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumawat |
| Designation |
Head Medical Services and Clinical Development |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room no 302 3rd floor Medical services and clinical development departmentHimalaya Wellness Company Makali Bangalore KARNATAKA 562162 India
Bangalore Rural
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
8067549904 |
| Fax |
|
| Email |
rajesh.kumawat@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Manager Clinical Operations Medical Services and Clinical Development (R&D) |
| Affiliation |
Himalaya Wellness Company |
| Address |
3rd floor Medical services and clinical development department Himalaya Wellness Company Makali Bangalore
Bangalore Rural
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
08067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company Makali Bengalore Karnataka 562162 |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company Makali Bengaluru 562 162 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshay Dhanda |
Xplora Clinical Research Services Pvt Ltd |
Xplora Clinical Research Services Pvt Ltd
Krishna Arcade 3rd Floor #23 5th Main, 12th Cross,
Wilson Garden Hombegowda Nagar Bangalore 560027
Bangalore
KARNATAKA |
95997 94872
akshay.dhanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Improving Exercise Performance |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shilajit, Reference: Shilajit shots, Route: Oral, Dosage Form: Dravaka, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. 18-40 years predominantly males and fitness enthusiastic females.
2. Athletes, sports or fitness enthusiasts engaged in regular resistance training (comprising of cardio and strength training like pushups, bench press, leg press, squats etc) from last 6 months for at least 5 days in a week and willing to continue throughout the study duration.
3. Subjects who agree to perform physical activities as stated in the protocol.
4. Subjects who agree not to start any new therapies or energy boosting supplements or protein supplements or health drinks during the study.
5. Subjects who have not participated in any other similar clinical study in the last 3 months.
6. Subjects willing to sign informed consent and follow the study procedure.
7.Women of child-bearing potential must agree to use adequate contraception during study period
8.Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
2.Subjects with known clinically significant neurological, respiratory, cardiovascular, gastrointestinal, hepatic, congenital or any other chronic disorder that can interfere with the study conduct in the opinion of the Investigator.
3.Subjects with known history or present condition of allergic response to any of the ingredients in the investigational product.
4.Pre-existing systemic diseases (auto immune disorders, hormonal replacement, etc.) necessitating long-term medications or any other such as bleeding disorders.
5.Pregnant as assessed by UPT & History of Amenorrhea and lactating women.
6.Known history of drug abuse/dependency that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions, study procedures or follow-up guidelines.
7.Any other conditions (physical, psychological, social or uncontrolled dietary measures) that can interfere with the participant’s compliance to the study in the opinion of the Investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in workout performance and muscle endurance using Push-up test.
Improvement in muscle strength & muscle recovery using Hand Grip Strength test.
Improvement in Energy Stamina Muscle Endurance Strength Muscle Recovery and Workout Performance through Subject Perception questionnaire. |
Visit 1: Screening/Day 1
Visit 2: Day 30 ± 2 days
Visit 3: Day 60 ± 2 days
Visit 4: Day 90 ± 2 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of safety of Investigational Product through General Physical Examination & Laboratory Investigations.
Incidence of adverse events during the study period.
Assessment of GI (Gastrointestinal) tolerability through GSRS (Gastrointestinal Symptom Rating Scale).
Proportion of subjects withdrawing from trial because of adverse events (tolerability). |
Visit 1: Screening/Day 1
Visit 2: Day 30 ± 2 days
Visit 3: Day 60 ± 2 days
Visit 4: Day 90 ± 2 days
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/05/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
| Participants will be examined for eligibility during the screening period after signing the informed consent form. An adequate number of participants who are Athletes, sports or fitness enthusiasts engaged in regular resistance training from last 6 months will be screened to enroll 50 participants, to have at least 40 evaluable participants. Participants will be enrolled based on study eligibility criteria (inclusion and exclusion criteria). After signing the informed consent form, eligible participants will be enrolled into the study. All the participants will be given IP on the same day(During screening visit). The date of first IP administration will be considered as Day1 and instructions about the dosage and timings will be given by Investigator as described in dosage & administration section. Core Endpoints Improvement in workout performance and muscle endurance using Push-up test. Improvement in muscle strength & muscle recovery using Hand Grip Strength test. Improvement in Energy, Stamina, Muscle Endurance, Strength, Muscle Recovery and Workout Performance through Subject Perception questionnaire. There will be a total of 4 study visits for each participant. Visit 1: Screening/Day 1 Visit 2: Day 30 ± 2 days Visit 3: Day 60 ± 2 days Visit 4: Day 90 ± 2 days/EOS | | |