| CTRI Number |
CTRI/2026/02/102801 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study to check the effects of HSHG 012601 on energy and performance in healthy adult men. |
|
Scientific Title of Study
|
An Open label, Prospective, Two Arm, Clinical Study to Evaluate the Safety and Efficacy of HSHG-012601 in Improving Energy levels and Performance in Healthy Adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/066/2025 V:1.0, Dated: 14th Jan 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshay Dhanda |
| Designation |
Consultant Orthopedics |
| Affiliation |
Xplora Clinical Research Services Pvt Ltd |
| Address |
Krishna Arcade 3rd
Floor, #23, 5th Main, 12th Cross, Wilson Garden
Hombegowda Nagar
Bangalore
KARNATAKA
560027
India |
| Phone |
9599794872 |
| Fax |
|
| Email |
akshay.dhanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haswathy Srinivasan |
| Designation |
Research Scientist Medical & Safety |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road
Bangalore
KARNATAKA
562162
India |
| Phone |
08067549915 |
| Fax |
|
| Email |
dr.haswathy.s@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Manager - Clinical Operations |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road
Bangalore
KARNATAKA
562162
India |
| Phone |
08067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company,
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore, 562162 |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company,
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore, 562162 |
| 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 |
Krishna Arcade 3rd
Floor, #23, 5th Main, 12th Cross, Wilson Garden, Hombegowda Nagar
Bangalore
KARNATAKA |
9599794872
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 |
Age 18 to 45 years fitness enthusiastic males. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shilajit Resin, Reference: NA, Route: Oral, Dosage Form: Guggulu, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 84 Days, anupAna/sahapAna: Yes(details: Twice a day with water), Additional Information: 250mg twice a day with water (after food) | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shilajit Resin, Reference: NA, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 84 Weeks, anupAna/sahapAna: Yes(details: Twice a day with water), Additional Information: 500mg twice a day with water (after food) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. 18 to 45 years fitness enthusiastic males.
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 atleast 5 days in a week and willing to continue through out the study duration.
3. Participants who agree to perform physical activities as stated in the protocol.
4. Participants who agree not to start any new therapies or energy boosting supplements or protein supplements or health drinks during the study.
5. Participants who have not participated in any other similar clinical study in the last
3 months.
6. Participants willing to sign informed consent and follow the study procedure.
7. Men with partners of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
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. Participants with physical impairments or musculoskeletal conditions that would
significantly interfere with their ability to safely and reliably perform the functional performance assessments specified in this protocol.
2. Participants with known or clinically significant neurological, respiratory, cardiovascular, gastrointestinal, hepatic, or other chronic medical conditions that, in the opinion of the Investigator, could compromise participant safety or interfere with study conduct or outcome interpretation.
3. Participants with a known history of allergy or hypersensitivity to any ingredient of the investigational product.
4. Participants with pre-existing systemic diseases (e.g., autoimmune disorders,
bleeding disorders) or those requiring long-term pharmacological treatment, including hormone replacement therapies, that could influence study outcomes or pose a safety risk, as determined by the Investigator.
5. Participants with a known history of substance abuse or dependency that, in the opinion of the Investigator, may limit their ability to comprehend informed consent or comply with study procedures, treatment instructions, or follow-up
requirements.
6. Any other medical, psychological, social, or lifestyle-related conditions, including
non-standardized dietary practices, that could interfere with participant compliance or affect study outcomes, as judged by the Investigator.
7. Participants who have used performance-enhancing supplements or substances, categorized as follows:
a) Short-term or acute-effect supplements (e.g., pre-workouts, stimulant-based formulations, or ergogenic aids) within 1 week prior to screening; or
b) Long-term anabolic or hormone-modulating substances (including but not limited to anabolic steroids, testosterone boosters, or growth hormone) within 8 to 12 weeks prior to screening, or during the study period.
8. Participants with a history of major surgery or hospitalization within the past 3–6 months, or those not fully recovered, as judged by the Investigator.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Objective Endpoints:
• Improvement in workout performance and muscle endurance using Push-up
test at Visit 2, Visit 3 & EOS compared to baseline.
Improvement in muscle strength & Post workout muscle recovery using Hand Grip Strength test at Visit 2, Visit 3 & EOS compared to baseline.
• Supports Hormonal Regulation (Testosterone & Cortisol)
ii. Subjective Endpoints:
• Improvement in Energy, Stamina, Endurance, Strength, Performance, Fatigue, Overall wellbeing at Visit 2, Visit 3 & EOS compared to baseline.
• Improvement in Post workout recovery using Likert-Type Muscle Soreness & Muscle fatigue Scale at Visit 2, Visit 3 & EOS compared to baseline. |
Day 1, Day 30, Day 56, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety Endpoints
• Incidence of adverse events
• Gastrointestinal Symptom Rating Scale (GSRS) |
Day 1, Day 30, Day 56, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/02/2026 |
| 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)
|
Not Yet Recruiting |
| 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
|
Protocol Number : HWC MSCD PP 066 2025 Version 10 Dated 14 Jan 2026 1 Study Title An Open Label Prospective Two Arm Clinical Study To Evaluate The Safety And Efficacy Of HSHG 012601 In Improving Energy Levels And Performance In Healthy Adults 2 Study Type : Interventional 3 Investigational Product IP: HSHG 012601 5 Sample Size Total Participants 60 Arm 1 30 Arm 2 30 6 Duration: Per Participant Duration 84 Days 7 Study Visits Total 4 Scheduled Visits And Unscheduled As Needed Visit 1 Screening Baseline Visit 2 Day 28 Visit 3 Day 56 Visit 4 End Of Study Day 84 Unscheduled Visit As Required For Safety Clinical Reasons 8 Study Population Healthy Males 18 To 45 Years Fitness Enthusiasts Gym Goers Athletes Or Sports Enthusiasts 9 Study Design Open Label Prospective Two Arm Clinical Study 10 Study Objectives Primary Objective To Evaluate The Safety And Efficacy Of HSHG 012601 In Healthy Adults 11 Study Endpoints A. Objective Endpoints Improvement In Workout Performance And Muscle Endurance Using Push Up Test At Visit 2 Visit 3 And End Of Study Compared To Baseline Improvement In Muscle Strength And Post Workout Muscle Recovery Using Hand Grip Strength Test At Visit 2 Visit 3 And End Of Study Compared To Baseline Supports Hormonal Regulation Testosterone And Cortisol B. Subjective Endpoints Improvement In Energy Stamina Endurance Strength Performance Fatigue Overall Wellbeing At Visit 2 Visit 3 And End Of Study Compared To Baseline Improvement In Post Workout Recovery Using Likert Type Muscle Soreness And Muscle Fatigue Scale At Visit 2 Visit 3 And End Of Study Compared To Baseline C. Safety Endpoints Incidence Of Adverse Events Gastrointestinal Symptom Rating Scale GSRS Reduction From Baseline |