FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/04/051658 [Registered on: 17/04/2023] Trial Registered Prospectively
Last Modified On: 24/05/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Efficacy and Safety of Nipple Care Butter in Prevention and Treatment in the Cracks, Soreness and Dryness of Nipples in Pregnant Women and Post-Partum Women 
Scientific Title of Study   An Open Label, Two Group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Nipple Care Butter in Prevention and Treatment in the Cracks, Soreness and Dryness of Nipples in Pregnant Women and Post-Partum Women 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HWC/MSCD/CPD/005/2023, version 1.0, dated 16 Feb 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Radhika S Kamuni 
Designation  MBBS, DGO, DNB, Consultant and Gynecologist 
Affiliation  SARV Advanced Multispeciality Clinic and Diagnostic Centre 
Address  SARV Advanced Multispeciality Clinic and Diagnostic Centre 74/1, Kaggadaspura main road, Vignan Nagar, Tippasandra Post, Bengaluru

Bangalore
KARNATAKA
560075
India 
Phone  8884393281  
Fax    
Email  drradhikakamuni@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swathi B 
Designation  Clinical Team Lead-Personal Care-Medical Services & Clinical Development (R&D) 
Affiliation  Himalaya Wellness Company 
Address  Room No. 1, Clinical Research Department, Makali, Bengaluru, India

Bangalore
KARNATAKA
562162
India 
Phone  8660837584  
Fax    
Email  dr.swathi.b@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  Mr Hasan Ali Ahmed 
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt. Ltd 
Address  No. 252, 13th Cross, Wilson Garden, Bengaluru

Bangalore
KARNATAKA
560027
India 
Phone  9886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company Makali, Bengaluru - 562162 
 
Primary Sponsor  
Name  Himalaya Wellness Company 
Address  Makali, Bengaluru - 562162 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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Soumya Mahesh Koregil  Hospitec Multi Speciality Hospital  #575, A Block, AECS Layout, Kudlu Bangalore- 560068
Bangalore
KARNATAKA 		 7411199000

soumyas100@gmail.com 
Dr Sunitha Mahesh   Milann Fertility and Birthing Hospital  #1109, 24th Main Road, TMC Layout, 1st Phase, J P Nagar, Bengaluru - 560078
Bangalore
KARNATAKA 		 9845354608

dr.sunithamahesh@gmail.com 
Dr Radhika S Kamuni  SARV Advanced Multispeciality Clinic and Diagnostic Centre  #74/1, Kaggadaspura main road, Vignan Nagar, Tippasandra Post, Bengaluru-560075
Bangalore
KARNATAKA 		 8884393281

drradhikakamuni@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
IIRRH-BACC Healthcare Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P929||Feeding problem of newborn, unspecified,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Himalaya Nipple Care Butter, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: -None
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1) Age: ≥ 18 years at recruitment.
2) Women with the following: ➢ Group-I: Healthy pregnant females (32 ± 2 weeks of pregnancy)
➢ Group-II: Lactating females: post-delivery having baby less than 3 months old.
3) Subjects with mild to moderate nipple cracks, dryness, soreness/ pain based on Visual Analog Score.
4) For post pregnancy mothers delivered baby within 37-42 weeks.
5) Subjects not having nipple abnormalities (e.g., flattening, indenting, bulging, or any apparent nipple deformity).
6) Subject is willing to give written informed consent and is willing to follow the study procedure.
7) The subject is willing to use test product throughout the study period. 
 
ExclusionCriteria 
Details  1) Subjects with high-risk pregnancy.
2) Subjects with severe breast inflammation/Mastitis requiring systemic treatment.
3) History of breast abscess, fungal infections.
4) Known case of dermatological disorders.
5) Subjects delivered abnormal baby.
6) Mothers with babies unable to take feed directly.
7) Subjects with severe nipple cracks, cuts, bleeding, severe pain.
8) Bad obstetric history.
9) Breast Hypoplasia.
10) Having other breast pathology (Breast infection, carcinoma, mastitis, bloody discharge etc.).
11) Women with skin allergies or taking medications for skin allergies.
12) Subjects not willing to discontinue other nipple crack preventing method during application.
13) Subjects who are taking any pain management medication e.g., NSAID’s, pain killers, etc.
14) Subject in a similar clinical study within the previous 4 weeks.
15) Women who are unable to give informed consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) To assess the mildness, gentleness, moisturization and soothing of the test product on skin by the Investigator.
2) To evaluate the symptoms assessment using 10-point scoring scale by Investigator.
3) To determine the experience of test product perception and subjective feedback of test product usage on nipples (softens and moisturizes the skin, non-sticky, safe in pregnancy, nipple conditioning before initiating breastfeeding) using questionnaires. 		 Day 1, Day 7, Day 42 
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate the safety of test product in babies by paediatric assessment scale.
2) To determine the experience of test product perception and subjective feedback questionnaire of test product usage on nipples (starts showing relief from 1st use, heals rashes, soothes cracked and sore nipples, reduction in pain, itchiness, dryness, softness and moisturizes the skin, non-sticky, safe for lactating females, breast feeding mother felt eases pain and discomfort, safer for babies too, helps improving breast feeding experience) using questionnaires.
3) To evaluate the product safety by occurrence AEs and SAEs. 		 Day 1, Day 7, Day 42 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   28/04/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
An open-label, two groups, multicenter clinical study to evaluate safety and efficacy of Nipple Care Butter in prevention/conditioning of nipples in pregnant women and treatment/reduction in the cracks, soreness and dryness of nipples in post-partum women. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits.
Group-I: The women with 32 week (± 2 weeks) of pregnancy till delivery:
• Screening/Baseline visit (Day 1/Visit 1)
• Follow up telephonic visit (Visit 2/Day 14)
• EOS/Visit 3 at week 38 (± 2 weeks) or date of delivery whichever is earlier.
Group-II: Post-Partum women (post-delivery up to 3 months) with nipple cracks, soreness and dryness of nipples.
• Screening/Baseline visit (Day 1/Visit 1),
• Follow up telephonic visit (Visit 2/Day 3 + 2)
• EOS/Visit 3 until the resolution/reduction of symptoms or maximum of 4 weeks. After the resolution of the symptoms, subjects will have to complete the EOS assessments.
A total of 150 evaluable subjects (50 pregnant women in Group-I & 100 post-partum women in Group-II above >18 years of age)
Group-I: Prevention in the cracks, soreness and dryness of nipple or associated symptoms in pregnant women (N=50)
Group-II: Treatment/reduction in the cracks, soreness and dryness of nipple in post-partum women (N=100)
Nipple Care Butter is lanolin-free, mineral oil free herbal composition with goodness of natural oils ideal for both expecting mothers in preparing the nipple for effective nursing and for lactating mothers in the prevention and management of sore and cracked nipples.
Instructions of Use: Apply Nipple Care Butter to the nipple and areola and massage gently, or as directed by your gynaecologist.
• Group-I: Twice daily for conditioning (prevention aspect in pregnant ladies)
• Group-II: For lactating mothers, we may proceed with directions as apply after each feeding/in between feed, as often as needed with instruction to wipe/clean the nipples before feeding. 
Following assessments will be recorded-Investigator Assessment Scale, Symptom Assessment Scale, Visual Analog Scale (VAS), Paediatric Assessment Scale and Subjective Assessment Questionnaire.
 
Close