| CTRI Number |
CTRI/2019/09/021400 [Registered on: 24/09/2019] Trial Registered Prospectively |
| Last Modified On: |
23/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Safety and Efficacy of HQMZ111831 as a Lactation Support to feeding Mothers |
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study to Evaluate the Safety and Efficacy of HQMZ111831 as a Lactation Support in Lactating Mothers |
| Trial Acronym |
Quista_Momz |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/010/2019 Version Number: 1.0, Dated: 21JUN2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena BT |
| Designation |
Obstetrics |
| Affiliation |
Multi speciality clinic |
| Address |
Multi speciality clinic,
Building of Shridhar Medical Shop, Near Rama Mandir,
Gynecology Department, Room No. 1, 3rd Floor, 3rd cross, 15th Main,3rd Block, Rajajinagar, Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
|
| Fax |
|
| Email |
veenaprabhubt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Palaniyamma |
| Designation |
Medical Advisor |
| Affiliation |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.palani@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palaniyamma |
| Designation |
Medical Advisor |
| Affiliation |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company
Makali, Tumkur Road, Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.palani@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company
Makali, Tumkur Road, Bangalore - 562162
|
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
Makali, Tumkur Road, Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Veena |
Multi speciality clinic |
Building of Shridhar Medical Shop, Near Rama Mandir,
Gynecology Department, Room No. 1, 3rd Floor, 3rd cross, 15th Main,3rd Block, Rajajinagar
Bangalore
Bangalore
KARNATAKA |
9880033626
veenaprabhubt@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 |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No comparator |
No comparator |
| Intervention |
Quista Momz |
This is an open label clinical study. Initially, subjects will be initiated for the informed consent process and then adequate subjects will be screened to have 40 evaluable subjects enrolled for the study post eligibility check. All 40 eligible subjects will receive 25g of HQMZ111831 twice daily oral with 200ml lukewarm milk for a period of 60 days. Schedule visits for the study would be Day 1, Day 30± 3 days (telephonic visit), Day 60± 3 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Lactating mothers aged ≥18 years ≤40 years and has completed 48 hours of post-partum period, who are planning at least three months of breast feeding to the infant
Mother confirms her intention to breastfeed and refrains from joining work outside during the study period.
Mother is non-smoker and non-alcoholic.
Infant is judged to be in good health.
Mothers planning only with the conventional breast feeding method and not intending to use breast pump.
Mother confirms her intention to breastfeed and refrains from taking any other
supplement or galactogogues during the study period.
|
|
| ExclusionCriteria |
| Details |
Mother has any anatomical defect in the breast or nipple like mastectomy, retracted nipples which may interfere with the normal breast feeding.
Mother is allergic or intolerant to any ingredient found in the study product.
An adverse maternal, fetal or infant medical history that has potential effects on child growth and or development.
Mother and or newborn infant has major illness that requires intensive care admission.
Infant has major congenital anomaly.
Infant with cleft lip, palate which may impair breast feeding. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of HQMZ111831 in improving the lactation in lactating mothers. |
Schedule visits for the study would be Day 1, Day 30 days (telephonic visit), Day 60 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety and tolerability of HQMZ111831 and overall compliance to the
product
|
Schedule visits for the study would be Day 1, Day 30 days (telephonic visit), Day 60 days. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/10/2019 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label
clinical study. Initially, subjects will be initiated for the informed consent
process and then adequate subjects will be screened to have 40 evaluable subjects
enrolled for the study post eligibility check. All 40 eligible subjects will receive 25g of
HQMZ111831 twice daily oral with 200ml lukewarm milk for a period of 60 days. Schedule visits for the study would be Day 1,
Day 30± 3 days (telephonic visit), Day 60± 3 days. |