| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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, nipple shields,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. |