| CTRI Number |
CTRI/2024/09/073330 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Study on a Supplement to Help Improvement of Breast Milk Production in Post-partum Lactating Women. |
|
Scientific Title of Study
|
A Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of HGLG-032406 as a Galactagogue Supplement in Post-partum Lactating Women. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/021/2024 Version No 1.0, Dated: 08th Aug 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena BT |
| Designation |
Gynaecologist, MBBS, MS(OBG) |
| Affiliation |
Sidvin Hospital Pvt.Ltd |
| Address |
Sidvin Hospital Pvt.Ltd.
Hospital Address:20th main road,5th Block,Jedara Halli, Rajajinagar
Bangalore
KARNATAKA
560010
India |
| Phone |
9880033626 |
| Fax |
|
| Email |
veenaprabhubt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjita |
| 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
KARNATAKA
562162
India |
| Phone |
8067549920 |
| Fax |
|
| Email |
dr.ranjita.s@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
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 – 562 162, Karnataka
|
|
|
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
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunitha B |
Milann - The Fertility Center Hospital |
1109, 24th Main road ,TMC layout 1st phase ,J.P. Nagar. 560078
Bangalore
KARNATAKA |
9845354608
drsunithamahesh@gmail.com |
| Dr Sneha Naveen |
Shradha Nursing Home |
#63, 5th Main, Mallappa Reddy Layout, Opp. Shiva Theater, Koramangala 8th Block, Bangalore-560095
Bangalore
KARNATAKA |
9035178834
snehamegha77@yahoo.co.in |
| Dr Veena BT |
Sidvin Hospital Pvt.Ltd. |
20th main road,5th Block,Jedara Halli,Rajajinagar
Bangalore
KARNATAKA |
9880033626
veenaprabhubt@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IIRRH-BACC Healthcare Institutional Ethics Committee |
Approved |
| Pranav Diabetes Center Ethics Committee |
Approved |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post-partum women |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shatavari, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 84 Days, anupAna/sahapAna: No, Additional Information: Dosage: 2 scoopfuls (10gms) twice daily with one glass of milk. | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Similar looking placebo , Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 84 Days, anupAna/sahapAna: No, Additional Information: Dosage: 2 scoopfuls (10gms) twice daily with one glass of milk. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy women between 20 to 45 years with or without lactation insufficiency.
2. Women who are in between 3-15 days of postpartum.
3. Women with uncomplicated full-term delivery (only vaginal or LSCS).
4. Women who are willing to exclusively breastfeed their infants.
5. Women with body mass index (BMI) 18.5-29.9 kg/m2.
6.Women having a healthy infant with a birth weight ranging from 2.5 kg to 4.5 kg and an Apgar score of 7 or higher. In specific instances, at the discretion of the investigator, healthy infants born pre-term or early term with a birth weight below 2.5 kg may also be included in the study.
7.Women who have not participated in any clinical study in the past 1 year.
8. Women willing to sign informed consent and follow the study procedure.
|
|
| ExclusionCriteria |
| Details |
1.Post-partum women with contraindications to breastfeeding, such as HIV, chemotherapeutic drugs, radioactive substances, and others as determined by the investigator.
2.Post-partum women with clinically significant health conditions (i.e., post-partum hemorrhage, sepsis).
3.Women with known allergies to any of the ingredients of investigational product.
4.Women already using proprietary drugs / supplements that have galactagogue properties.
5.Women with insufficient glandular tissue or breast surgery and any structural abnormality of the breast.
6.Women with triplets or more.
7.Women with genetic or hormonal disorders causing prolactin deficiency.
8.Women with hyperlactation symptoms like frequent blocked ducts or mastitis, leaking a lot of milk between feedings, full or uncomfortable breast even after feeding.
9. Mothers and/ or infants with galactosemia.
10.Infants with sucking problems or congenital anomalies (cleft lip, cleft palate), birth trauma, premature birth.
11. Women having history of alcoholism, smoking or other substance use according to DSM-V criteria.
12. Women with known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological, or neurological illnesses.
13. Mother and/or infants with major illness that requires intensive care admission/any pregnancy or parturition related clinically significant conditions.
14. Women with any other reason (physical, psychological, or social) that can interfere with the compliance to the study in the opinion of the Investigator. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy;
1.Change in volume (ml) of breast milk produced after breast fullness, measurement by breast pump(Manual/Automatic).
2.Mean change in serum prolactin levels in post-partum women.
3.Improvement in perceived insufficient milk questionnaire scoring.
4.Mean change in infant weight after delivery. |
Day1, Day 28 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. General Physical Examinations
2. Laboratory Examinations
3. Incidence of adverse event reporting.
4. Organoleptic product feedback. |
Day1, Day 28 and Day 84 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "135"
Final Enrollment numbers achieved (India)="135" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
14/09/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of HGLG-032406 as a Galactagogue Supplement in Post-partum Lactating Women. Objective: To evaluate the efficacy and safety of HGLG-032406 as a galactagogue supplement in post-partum lactating women. Study Design: Randomized, Double-Blind, Placebo-Controlled Clinical Study Study Population: Post-partum women aged 20-45 who meet specific inclusion criteria, including healthy women with or without lactation insufficiency, willing to exclusively breastfeed their infants. Intervention: HGLG-032406 (galactagogue supplement) or similar-looking placebo (nutritional supplement without lactogenic effect) administered for 12 weeks. Endpoints: 1. Change in volume (ml) of breast milk produced after breast fullness, measurement by breast pump(Manual/Automatic). 2. Mean change in serum prolactin levels in post-partum women. 3. Improvement in perceived insufficient milk questionnaire scoring. 4. Mean change in infant weight after delivery. 5. General Physical Examinations 6. Incidence of adverse events. 7. Organoleptic product feedback
Study Visits: There will be 3 study visits for each subject: - Visit 1 - Screening/Enrolment/Baseline Visit
- Visit 2 - At the end of 4th week (Day 28 ± 4 days)
- Visit 3 - At the end of 12th week (Day 84 ± 4 days)/End of Study (EOS).
Dosage: 2 scoopfuls (10gms) twice daily with one glass of milk.
This study aims to assess the safety and efficacy of HGLG-032406 as a galactagogue supplement in post-partum lactating women, with a target sample size of 120 evaluable subjects. |