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CTRI Number  CTRI/2026/02/104903 [Registered on: 26/02/2026] Trial Registered Prospectively
Last Modified On: 27/08/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate whether Lactare Plus® helps increase breast milk production in mothers after delivery. 
Scientific Title of Study   A Randomized, Multi-Centered, Two-Arm, Double-Blind, Placebo-Controlled Clinical Trial for Generating Evidence on The Efficacy of the Herbal Galactagogue Lactare Plus for Augmentation of Lactation Among Postpartum Mothers 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
ECR/2025/007  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hanee Hemantkumar Patel 
Designation  MD Gynecology 
Affiliation  Harmony Hospital  
Address  301, 401, 402, Pushkar Icon, above Croma Nr. Shukan Cross Road, Nikol- Naroda Road, Ahmedabad- 382350

Ahmadabad
GUJARAT
382350
India 
Phone  8140125804  
Fax    
Email  haneepatel6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhaumik Mody  
Designation  Head Clinical Research and RWE - Medical Affairs 
Affiliation  Mankind Pharma Ltd. 
Address  Okhla Industrial Estate, Phase III, New Delhi 110020, India

New Delhi
DELHI
110020
India 
Phone  01146541111  
Fax    
Email  bhaumik.mody@mankindpharma.com  
 
Details of Contact Person
Public Query  
Name  Amardeep Sharma 
Designation  CEO 
Affiliation  Eccentric Clinical Research Pvt Ltd 
Address  305 and 306, Near City Pulse Cinema, SMVS Hospital Road, Raysan, Gandhinagar-382421, Gujarat (India)

Gandhinagar
GUJARAT
382421
India 
Phone  7309300319  
Fax    
Email  amardeep.sharma@eccentriccr.com  
 
Source of Monetary or Material Support  
Mankind Pharma Limited, Okhla Industrial Estate, Phase III, New Delhi, India – 110020 
 
Primary Sponsor  
Name  Mankind Pharma Ltd 
Address  Okhla Industrial Estate, Phase III, New Delhi – 110020, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gautam Sheladiya  G B Vaghani Multispeciality Hospital  75-80, Ishwarkrupa Society Opp. Maharana Pratap Udhyan, Varachha Main Rd, Chowpatty, Varachha, Surat, Gujarat 395013
Surat
GUJARAT 		 9510099364

gbvaghanicr@gmail.com 
Dr Nitin Sutariya  Global Super Specialty and Cancer Hospital,   Block no: 108, old survey no. 111 Emerald Avenue Surat-Kamrej Road, valak char rasta 394180, Gujarat
Surat
GUJARAT 		 9099014100

globalhopsitalcr@gmail.com 
Dr Hanee Hemantkumar Patel  Harmony Hospital   301, 401, 402, Pushkar Icon, above Croma Nr. Shukan Cross Road, Nikol- Naroda Road, Ahmedabad- 382350
Ahmadabad
GUJARAT 		 81401125804

haneepatel6@gmail.com 
Dr P Josephin Rosy  Madha Medical College and Research Institute   Kundrathur Main Road, Kovur, Thandalam, Chennai - 600128
Chennai
TAMIL NADU 		 7708240555

drjomadan2@gmail.com 
Dr Shobha Gaurav Vadher  Medilink Hospital and Research Center Pvt Ltd  Satellite, 132 Feet Ring Rd, Opposite Someshwar Jain Temple Derasar, Nehru Nagar, Ambawadi, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT 		 9825047961

drshobhavadher@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Global Ethics Committee  Approved 
Global Ethics Committee  Approved 
IEC Shashvat Surgicare Hopsital   Approved 
KVT Multispeciality Hospital - Institutional Ethics Committee  Approved 
Medilink Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O924||Hypogalactia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lactare Plus® plus non-pharmacological interventions  Lactare Plus® , one capsule administered orally twice daily for 30 consecutive days, preferably post-breastfeeding with adequate water or milk.  
Comparator Agent  Matching Placebo plus Non-pharmacological interventions  Matching placebo capsules, one capsule administered orally twice daily for 30 consecutive days, preferably post-breastfeeding with adequate water or milk.  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Healthy female trial participants aged more than or equal to 19 years undergone an uncomplicated delivery
2. Trial participants willing to provide written informed consent and comply with the study visit schedule and procedures.
3. Singleton/twin live birth, gestational age more than or equal 37 weeks.
4. Absence of lactation within 72 hours post-delivery, or as determined by the Principal Investigator.
5. Intends to continue breastfeeding for at least 5 weeks. 
 
ExclusionCriteria 
Details  1. Infants with malformations that could affect feeding or growth.
2. Infants with illness or mothers with severe illness or severe malnutrition.
3. Lactating women who have a diagnosis of mastitis.
4. Lactating women with debilitating chronic illness.
5. Lactating women consuming any other galactagogue.
6. Any other medical conditions or medications, according to the investigator, would interfere directly with the results of the study or jeopardize the health of the participant.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of exclusive breastfeeding, post-delivery as measured by scores on the Humenick or Hill Lactation Scale (HHLS) and Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF) questionnaire.  Baseline and EOS 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduction in supplemental milk intake.
2. Mean change in infant weight gain.
3. Mean change in serum prolactin levels
4. Total volume of supplemental milk required for infants.
5. Incidence and severity of adverse events (AEs) and treatment-emergent adverse events (TEAEs) related to Lactare Plus® supplementation.
 		 1. Baseline and EOS
2. Baseline and EOS
3. Baseline and EOS
4. Baseline and EOS
5. throughout the study period 
 
Target Sample Size   Total Sample Size="228"
Sample Size from India="228" 
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   N/A 
Date of First Enrollment (India)   09/03/2026 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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 randomized, multi-centered, two-arm, double-blind, placebo-controlled clinical study will enroll postpartum mothers experiencing delayed onset of lactation. Participants will be randomized in a 1:1 ratio using block randomization to receive either Lactare Plus® capsules combined with standardized non-pharmacological breastfeeding support or matching placebo capsules combined with standardized non-pharmacological breastfeeding support. This design will allow evaluation of the efficacy and safety of Lactare Plus® in augmenting lactation compared to placebo when both groups receive identical structured non-pharmacological breastfeeding support. 
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