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CTRI Number  CTRI/2025/07/090584 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   Study conducted to see the efficacy of Madhuka Ghrita lepana in Nipple crack in lactating women 
Scientific Title of Study   A Clinical Study to Evaluate the Efficacy of Madhuka Ghrita Lepana in Nipple Crack in Lactatig women 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Veena G Kadeli 
Designation  PG Scholar PTSR 
Affiliation  Rajarajeshwari Ayurvedic Medical College Hospital and PG Center Humnabad Bidar 
Address  Department of PG Studies in PTSR Rajarajeshwari Ayurvedic Medical College Hospital and PG Center Humnabad Bidar

Bidar
KARNATAKA
585330
India 
Phone  9482541586  
Fax    
Email  kadeliveena@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR N Sudhakar 
Designation  Professor 
Affiliation  Rajarajeshwari Ayurvedic Medical College Hospital and PG Center Humnabad Bidar 
Address  Department of PG Studies in PTSR Rajarajeshwari Ayurvedic Medical College Hospital and PG Center Humnabad Bidar

Bidar
KARNATAKA
585330
India 
Phone  9866691084  
Fax    
Email  dr.nsr65@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR N Sudhakar 
Designation  Professor 
Affiliation  Rajarajeshwari Ayurvedic Medical College Hospital and PG Center Humnabad Bidar 
Address  Department of PG Studies in PTSR Rajarajeshwari Ayurvedic Medical College Hospital and PG Center Humnabad Bidar


KARNATAKA
585330
India 
Phone  9866691084  
Fax    
Email  dr.nsr65@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeshwari Ayurvedic Medical College Hospital and PG Center Humnabad District: Bidar Karnataka 585330 India  
 
Primary Sponsor  
Name  Rajarajeshwari Ayurvedic Medical College Hospital and PG Center  
Address  Department of PG Studies in PTSR Rajarajeshwari Ayurvedic Medical College Hospital and PG Center Humnabad District: Bidar Karnataka Pin code:585330 India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 G Kadeli  Rajarajeshwari Ayurvedic Medical College Hospital and PG Center   Department of PG Studies in PTSR Rajarajeshwari Ayurvedic Medical College Hospital and PG Center Humnabad Bidar
Bidar
KARNATAKA 
9482541586

kadeliveena@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Rajarajeshwari Ayurvedic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: STANYAVAHA-SROTODUSHTI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Dravyaguna, Procedure details: External application of Madhukaghrita 3 times a day for about 1 hr over cracked nipple for a period of 7 dayas)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Lactating women
1.Who are between 20 to 40 years
2.Having nipple crack and pain
3.Irrespective of nature of Delivery
4.Nipple trauma score-3 
 
ExclusionCriteria 
Details  Lactating women with symptoms of
1.Mastitis
2 Histroy of Breast abscess
3.Known case of Dermatological disorders
4.Known case of Nipple abnormalites 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To know the Efficacy of Madhuka ghrita lepana in Nipple crack in Lactating women  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the Efficacy of Madhuka ghrita lepana in Nipple crack in Lactating women  7days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   28/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

 

NEED FOR THE STUDY:

 

Nipple areolar complex appears painful due to loss of surface epithelium with formation of raw area or due to

a fissure at tip or base of nipple.These two conditions frequently co-exist and is termed as cracked nipple.1In ayurveda nipple crack can be correlated with ‘Ghrista sadyovrana as it is characterized by vigatatwak

occurring due to gharshana or abhighata.

 

Acharya charaka  mentioned about stana sampat laxanas  in shareera sthana 8th chapter 53 sloka as stana

should not be situated at very high level,they should  not  hang very loose,they should neither be very lean

nor very plump.  They should have nipples of proportionate size. The child should find it easy to suckle them.3

 

Cracked nipple is extremely painful when infants sucks,that interferes breast feeding and cause premature weaning.when infected,it may spread to deeper tissue producing mastitis.4 In Astanga Hrudaya utharsthanamsadhyovrana pratishedhan adhyayam a reference about madhukaghrita is explained.5

 

The study drug madhuka (Glycyrrhiza glabra) is vrana Shodhana ropanaand varnakrit.6 It possess anti-inflammatory ,and antioxidant properties,itcontains glycyrrheinitic acid which promote the migration of

dermal fibroblast and promotes wound healing.7 Cracked nipple means any type of damage to nipple or

around areolar region associated with or without pain.It appears as cracks/ small lacerations or breaks on

skin of nipple.8

 

Contemporary treatments includes usage of glycerine nipple pads, nipplshields,creams,lotions,ointments

eg Lanolin ).The incidence of nipple crack is higher with in first 30days of postpartum period. 

Prevalence rate of nipple crack shows that 32% mothers is having cracked nipple with in first month of postpartum period.9Among them 80-90% experience nipple pain that can results in early weaning. Ongoing research works in the field of nipple crack still prove that herbal preparations with peppermint,pisticiaatlantica showed better result than lanolin.Even though nipple crack is effectively managed in ayurveda ,systematic assessment and documentation has not been done.

 

 

 
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