| CTRI Number |
CTRI/2026/04/107646 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To investigate the safety and Tolerability of HGTX-072512 in Healthy Volunteers |
|
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 HGTX-072512 in Healthy Adults. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/049/2025 Version no: 1.0, Dated: 03 Nov 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sridhar Sreenivasan G |
| Designation |
Principal Investigator |
| Affiliation |
TrialGuna Private Limited |
| Address |
Room no. 3, 1st floor, 467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block, Bangalore, Karnataka-560083, India
Bangalore
KARNATAKA
560083
India |
| Phone |
9535234132 |
| Fax |
- |
| Email |
lgsridhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haswathy Srinivasan |
| Designation |
Research Scientist- Medical and Safety |
| Affiliation |
Himalaya Wellness Company(HWC) |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road Bangalore Karnataka, India
Bangalore
KARNATAKA
562162
India |
| Phone |
08067549915 |
| Fax |
- |
| Email |
dr.haswathy.s@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Naryanan H |
| Designation |
Manager-Clinical Operations |
| Affiliation |
Himalaya Wellness Company(HWC) |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road Bangalore Karnataka.
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 |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road Bangalore Karnataka 562162 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 Sridhar Sreenivasan G |
TrialGuna Private Limited |
Room no. 3, 1st floor, 467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block, Bangalore, Karnataka-560083, India.
Bangalore
KARNATAKA |
9535234132
-
lgsridhar@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 |
Healthy adults |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: HGTX-072512, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 270(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Cohort 1 and 3 – OD and Cohort 2 and 4 - BD | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 270(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Cohort 1 and 3 – OD and Cohort 2 and 4 - BD |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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.
3. Healthy adults who refrain from taking any oral/ 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 clinical study within the last 3 months of screening.
5. Healthy adults who are willingly informed consent and follow the study procedure. |
|
| ExclusionCriteria |
| Details |
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. (Participants 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 significant systemic illness or disorder/ or any other gastrointestinal malignancy/bleeding disorder/Gastrectomy/ history of structural disease in upper GIT (Eg: Ulcer, surgery etc).
4. Patients currently taking medications like antacids, anti-emetics, laxatives or any other for the treatment of gastrointestinal disorders.
5. Patients with pre-existing systemic diseases (auto immune disorders, hormonal replacement etc.) necessitating long-term medications.
6. Patients with any current infections (bacterial, fungal, viral) at the time of screening as determined by the investigator.
7. Pregnant as assessed by UPT & history of amenorrhea and lactating women.
8. Women of child-bearing potential who are refusing to use adequate contraception throughout the study period.
9. Males who are refusing to use adequate contraception throughout the study period and refusing from donating sperm from first admission to the study until 90 days after the study completion.
10. 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.
11. 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 0, Day 1 to Day 7+1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
20/04/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 Phase 1 clinical study is designed to evaluate the safety and
tolerability of HGTX-072512, a herbal formulation developed by
Himalaya Wellness Company, in healthy adult volunteers. The study follows a
randomized, double-blind, placebo-controlled, multiple cohorts, sequential
dose escalation design.
A total of 40 healthy male and female participants aged between 18 and <45
years will be enrolled and divided into four cohorts of ten participants each
(seven receiving HGTX-072512 and three receiving placebo). The
investigational product will be administered orally for seven days (with a +1-day
window) in escalating doses.
The dose escalation will proceed from one cohort to the next only after
evaluation of safety and tolerability data from the preceding cohort. The
planned dose regimen is as follows: Cohort 1 – one tablet once daily, Cohort
2 – one tablet twice daily, Cohort 3 – two tablets once daily, and Cohort 4 –
two tablets twice daily.
Safety assessments will include monitoring of adverse events, vital signs,
physical and systemic examinations, electrocardiogram, laboratory
investigations, and gastrointestinal tolerability using the Gastrointestinal
Symptom Rating Scale (GSRS).
The study aims to establish the safety profile and gastrointestinal
tolerability of HGTX-072512 in healthy adults, providing the basis for
further clinical development of the formulation for Dyspepsia / Indigestion.
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