| CTRI Number |
CTRI/2024/04/066274 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety Evaluation of HGLG-032406 in Healthy Adult Females |
|
Scientific Title of Study
|
An Open-Label, Single Arm Clinical Study to Evaluate the Safety of HGLG-032406 (IN-100001206) in Healthy Adult Females. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/006/2024 Version 1.0, Dated 25th Mar 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Radhika S Kamuni |
| Designation |
MBBS, DGO, DNB - Obstetrics & Gynecology |
| Affiliation |
Xplora Clinical Research Services Pvt Ltd |
| Address |
Xplora Clinical Research Services Pvt Ltd
#252, 13th cross, Wilson Garden, Bangalore
Bangalore
KARNATAKA
560027
India |
| Phone |
8884393281 |
| Fax |
|
| Email |
drradhikakamuni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anindya Dasgupta |
| Designation |
Scientific Manager |
| Affiliation |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D),
Makali Tumkur Road, Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549920 |
| Fax |
|
| Email |
dr.anindya@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Manager-Clinical Operations |
| Affiliation |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D),
Makali Tumkur Road, Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549919 |
| 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, Karnataka, India– 562 162 |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore – 562 162
|
| 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 Radhika S Kamuni |
Xplora Clinical Research Services Pvt Ltd |
#252, 13th cross, Wilson Garden, Bangalore - 27
Bangalore
KARNATAKA |
8884393281
drradhikakamuni@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 Adult Females |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Galactagogue Granules , Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Grasantara bhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy adult females within age group of 18 to 40 years.
2.Healthy females as determined by the investigator based on a medical evaluation including medical history, physical examinations, and laboratory examinations.
3.Subjects willing to sign an informed consent document.
4.Subjects willing to adhere to protocol requirements throughout the study period.
5.Subjects who have not participated in any clinical study in the past 30 days
|
|
| ExclusionCriteria |
| Details |
1.Subjects with known clinically significant serious cardiovascular, neurological, respiratory, gastrointestinal, genitourinary, congenital or any other disorder as determined by the investigator.
2.Women who are pregnant, nursing, or planning a pregnancy during study entry and throughout the duration of the study.
3.Subjects with lactose intolerance (as the IP is to be taken with milk).
4.Subjects with known allergies to any of the ingredients of the investigational product.
5.Subjects with clinically significant pre-existing systemic disease necessitating long-term medications as determined by the investigator.
6.Subjects not willing to refrain from using adequate contraception and hormonal medications one month prior and during the study.
7.Subjects not willing to refrain from taking any other similar supplements during the study period.
8.Subjects not willing to abstain from excessive intake of recreational products like tobacco/pan chewing, smoking, alcohol and any other as determined by the investigator during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety of Galactagogue in healthy adult females by the following assessments:
1. General Physical Examinations
2. Laboratory Examinations
3. Adverse events
|
Day 1 and Day 7
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse events (AE): AEs/SAEs will be continuously monitored throughout the duration of the study |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title: An Open-Label, Single Arm Clinical Study to Evaluate the Safety of HGLG-032406 (IN-100001206) in Healthy Adult Females. Protocol Number: HWC/MSCD/PP/006/2024 Version: 1.0, Dated 25th Mar 2024 Study Type: Interventional Duration: 7 days Number of Subjects: 12 evaluable subjects Study Arms: Single Arm Study Visits: 3 visits (Visit1: Screening, Visit 2:Baseline, Visit 3:End of study) Study Population: Healthy adult females aged 18 to 40 Study Design: Open-Label, Single Arm Clinical Study This single-arm clinical study aims to assess the safety of HGLG-032406 in healthy adult females over a 7-day period. The study will involve 12 evaluable subjects aged 18 to 40. Eligible subjects will receive the investigational product on Day 1 and will be monitored through three visits for general physical examinations, laboratory tests, adverse events, and feedback on product experience. Inclusion criteria emphasize overall health and willingness to adhere to the study protocol, while exclusion criteria include significant medical conditions, pregnancy, allergies, and unwillingness to refrain from certain substances during the study period. The dosage will be 10 grams twice daily with milk for 7 days.
|