CTRI

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CTRI Number

CTRI/2025/12/099819 [Registered on: 24/12/2025] Trial Registered Prospectively

Last Modified On:

01/12/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Other

Public Title of Study

To investigate the safety and Tolerability of HCFX-072515 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 HCFX-072515 in Healthy Adults

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
HWC/MSCD/PP/048/2025 Version 1.0 Dated 15OCT2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ratkal C S
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	9845255378
Fax	-
Email	dr.csratkal@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	Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road Bangalore KARNATAKA 562162 India Bangalore KARNATAKA 562162 India
Phone	08067549909
Fax
Email	rajesh.kumawat@himalayawellness.com

Details of Contact Person
Public Query

Name	Dr Soorya Narayan
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 562162 India Bangalore KARNATAKA 562162 India
Phone	08067549904
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

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ratkal C S	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	09845255378 - dr.csratkal@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

Status

Not Applicable

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: HCFX-072515, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 723(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Cohort 1 and 3 - OD 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: 723(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Cohort 1 and 3 - OD 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 females 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/ 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 the 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. (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 history of significant renal disease or urinary symptoms; past
history of urinary stones, or history of any previous urogenital invasive
procedures.
4. Patients with known history or present condition of allergic response to any
of the ingredients in the investigational product.
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. Adults who are not willing to refrain from alcohol or smoking from 48 hours
prior and during the study.
8. Pregnant as assessed by UPT & history of amenorrhea and lactating women.
9. Women of child-bearing potential who are refusing to use adequate
contraception throughout the study period.
10. 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.
11. 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.

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 and 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)

30/12/2025

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 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

This Phase 1 clinical study is designed to evaluate the safety and tolerability of HCFX-072515, a herbal formulation developed by Himalaya Wellness Company, in healthy adult volunteers. The study follows a randomized, double-blind, placebo-controlled, multiple cohort, 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 HCFX-072515 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 HCFX-072515 in healthy adults, providing the basis for further clinical development of the formulation for urinary tract and kidney health.