| CTRI Number |
CTRI/2026/01/100780 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study the Healing Effect of Sesame Seed Paste with Honey for Cracked Nipples in Breastfeeding Mothers. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Study The Effect Of Tila Kalka With Madhu Lepa On Stanachuchuka Vrana During Sutikavastha With Special Reference To Cracked Nipples. |
| 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 Prachi Sandip Chaudhari |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasutitantra and Striroga SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7387277338 |
| Fax |
|
| Email |
prachischaudhari2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradnya Prataprao Deshmukh |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasutitantra and Striroga SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9766310638 |
| Fax |
|
| Email |
drpradnya2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Sandip Chaudhari |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasutitantra and Striroga SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7387277338 |
| Fax |
|
| Email |
prachischaudhari2000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Prachi Sandip Chaudhari |
| Address |
Department of Prasutitantra and Striroga SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403 |
| Type of Sponsor |
Other [Self] |
|
|
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 Prachi Sandip Chaudhari |
SMBT Ayurved College and Hospital |
OPD No.5 Department of Prasutitantra and Striroga SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Ghoti Igatpuri Nashik 422403
Nashik
MAHARASHTRA |
7387277338
prachischaudhari2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O921||Cracked nipple associated with pregnancy, the puerperium, and lactation. Ayurveda Condition: SUTIKAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta Samhita Chikitsasthan 1/63-65, Procedure details: Tila (Sesame) seeds grinded with required quantity of water to form paste & mixed with required Madhu (Honey) & applied as Lepa on affected area (Cracked Nipples), 3 times a day for 7 Days.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Lanolin Ointment | Applied over Cracked Nipples. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. The signs and symptoms of Stanachuchuka Vrana like cracked nipple,
nipple pain during breastfeeding, irritation of nipples, redness.
2. Postnatal mothers within the age of 18-45 years. |
|
| ExclusionCriteria |
| Details |
1. Mastitis
2. Breast abscess
3. Congenital deformity like nipple inversion, flat nipples. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the signs and symptoms of Stanachuchuka Vrana like cracked nipple,
nipple pain during breastfeeding, irritation of nipples, redness.
Reduction in Nipple Soreness Rating Scale and Nipple Trauma Score. |
1) Total Duration of Treatment :- 7 Days
2) Assessment on Day 0, Day 4, Day 8
3) Follow up after 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
MIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
02/02/2026 |
| 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="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
|
TITILE :- A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF TILA KALKA WITH MADHU LEPA ON STANACHUCHUKA VRANA DURING SUTIKAVASTHA WITH SPECIAL REFERENCE TO CRACKED NIPPLES.
INTRODUCTION :- One of the common complication during the postpartum period is cracked nipples. Most common factors causing Cracked nipples are Poor Latch and Incorrect Breastfeeding Position. The prevalence of cracked nipples among breastfeeding mothers during the postpartum period is approximately 32%. If not treated it can produces further complications like infections, nipple thrush, mastitis, contact dermatitis, this can makes future breast feeding sessions uncomfortable, so it requires more attention and proper treatment. Given the potential side effects associated with modern medications, there is a growing interest in exploring Ayurvedic formulations for managing Stanachuchuka Vrana (Cracked Nipples). In light of this, the present study aims to investigate a safer and more effective alternative treatment based on Ayurvedic principles, with the goal of offering better outcomes and minimizing side effects. This research seeks to bridge the current gap in treatment options. Tila Kalka with Madhu exhibit both the properties. Both the drugs are easily available and have effective properties to heal Stanachuchuka Vrana.
SAMPLE SIZE :- Total sample size for the study will be 70 participants divided equally between trial and control group.
NULL HYPOTHESIS (H0) :- Tila Kalka with Madhu Lepa is not effective on Stanachuchuka Vrana during Sutikavastha.
ALTERNATE HYPOTHESIS (H1):- Tila Kalka with Madhu Lepa is effective on Stanachuchuka Vrana during Sutikavastha.
Trial and control drugs will be purchased from GMC certified pharmacy. Both drugs will be administered for 7 days.
|