| CTRI Number |
CTRI/2025/11/097873 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study to evaluate the safety and Tolerability of healthy Human Volunteers for a period of 7 days for safety end points. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Multiple Cohort, Sequential Dose Escalation Phase 1 Clinical Study to Evaluate the Safety & Tolerability of HLTX-072522 in Healthy Adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/034/2025 Version No: 1.0 Dated 14OCT2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendra Narayan Sharma |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block, Bangalore, Karnataka-560083, India
Bangalore
KARNATAKA
560083
India |
| Phone |
9740199006 |
| Fax |
- |
| Email |
dr.r.n.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumawat |
| Designation |
Head- Medical Services and Clinical Development |
| Affiliation |
Himalaya Wellness Company(HWC) |
| Address |
Makali, Bengaluru- 562 162, India.
Bangalore
KARNATAKA
562162
India |
| Phone |
08067549909 |
| Fax |
|
| Email |
rajesh.kumawat@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Naryanan |
| Designation |
Manager-Clinical Operations |
| Affiliation |
Himalaya Wellness Company(HWC) |
| Address |
Makali, Bengaluru- 562 162, India.
Bangalore
KARNATAKA
562162
India |
| Phone |
08067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company (HWC)
Makali, Bengaluru 562 162, India. |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company(HWC) |
| Address |
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 Rajendra Narayan Sharma |
TrialGuna Private Limited |
467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block, Bangalore, Karnataka-560083, India
Bangalore
KARNATAKA |
9740199006
-
dr.r.n.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adults |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Phyllanthus amarus, Achillea millefolium, Emblica officinalis,Tinospora cordifolia,Eclipta alba,Terminalia chebula Boerhavia diffusa Raphanus sativus Hedychium spicatum Tephrosia purpurea Cichorium intybus, Andrographis paniculata , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: ), Additional Information: (2) Medicine Name: Phyllanthus amarus, Achillea millefolium, Emblica officinalis,Tinospora cordifolia,Eclipta alba,Terminalia chebula Boerhavia diffusa Raphanus sativus Hedychium spicatum Tephrosia purpurea Cichorium intybus, Andrographis paniculata , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: ), Additional Information: | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: ), Additional Information: (2) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: ), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adults who meet all the following criteria will be included in the study.
1. Healthy adult male or female aged between 18 to less than 45 years with normal body mass index (BMI) 18.5-24.9 kg/m2.
2. Healthy adults as determined by the investigator based on a medical evaluation
including medical history, physical examination, laboratory tests-as specified in Appendix1.
3. Healthy adults who refrain from taking any oral and topical medication at least 15 days prior and during the study period-SOS medications to be allowed during the study for any specific medical condition like paracetamol for fever.
4. Healthy adults who have not participated in any other similar clinical study within the last 3 months of screening.
5. Healthy adults who willingly sign informed consent and follow the study procedure. |
|
| ExclusionCriteria |
| Details |
Adults who meet any of the following criteria will be excluded from the study.
1. Patients with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, congenital or any other systemic disorder that can interfere with the study conduct and outcome in the opinion of the
Investigator. (Patients with any chronic medical condition under control to be also excluded).
2. Patients with known history of GIT disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score (Appendix 2) more than 1 for any one of the 15 questions to be excluded).
3. Patients with known fatty liver disease grade 2 or more, history of chronic liver disease (like ALD/ DILI/MASLD, chronic viral hepatitis like hepatitis B, C).
4. Patients with known history of acute liver disease like acute hepatitis, within 6 months prior to the study (1)
5. Patients with history of major surgery (like cholecystectomy) and major procedures like MRCP, ERCP.
6. Patients with pre-existing systemic diseases (auto immune disorders, hormonal replacement etc.) necessitating long-term medications.
7. Patients with any current infections (bacterial, fungal, viral) at the time of
screening as determined by the investigator.
8. Pregnant as assessed by UPT & history of amenorrhea and lactating women.
9. Women of child-bearing potential who refrain to use adequate contraception throughout the study period.
10. Males who refrain to use adequate contraception throughout the study period and not willing to refrain from donating sperm from first admission to the study until 90 days after the study completion. (2)
11. Adults who are not willing to refrain from alcohol or smoking from 48 hours
prior and during the study.
12. Adults who undergo strenuous exercise within 7 days prior and during the
study. (3)
13. Known alcohol, any other substance abuse or any other reason (physical,
psychological, or social) that can interfere with the participant’s compliance to
the study in the opinion of the Investigator.
14. Patients with known history or present condition of allergic response to any of
the ingredients in the investigational product. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence of adverse events during the study period.
2. Proportion of participants withdrawing from trial because of adverse events (tolerability)
3. Gastrointestinal (GI) tolerability during the study period. |
Day 1 and Day 7 +1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
19/12/2025 |
| 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="3"
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
|
This is a randomized, double-blind, placebo-controlled, multiple-cohort, sequential dose-escalation, Phase 1 clinical study designed to evaluate the safety and tolerability of HLTX-072522, a proprietary herbal formulation developed by Himalaya Wellness Company, in healthy adult volunteers. A total of 40 participants will be enrolled and distributed into four cohorts, with 10 participants per cohort, randomized in a 7:3 ratio to receive either HLTX-072522 or placebo. Each cohort will receive a different dose regimen for 7 days (±1 day window)and Cohorts will be sequential recuritment. The study will comprehensively assess safety and tolerability through the evaluation of adverse events, vital signs, physical examinations, electrocardiograms (ECG), and clinical laboratory parameters such as hematology, biochemistry, and urinalysis. Given that HLTX-072522 is an orally administered herbal formulation, monitoring of gastrointestinal (GI) symptoms and parameters are included as a key part of the tolerability assessment. Observations for GI-related effects such as nausea, vomiting, abdominal discomfort, or altered bowel habits will help identify any local or systemic adverse effects associated with digestion and absorption. From an Ayurvedic perspective, maintaining optimal Agni (digestive function) and gut balance is fundamental for ensuring both the safety and systemic harmony of the formulation. This evaluation will help confirm the GI tolerance and overall safety profile of HLTX-072522, supporting its further clinical development. |