| CTRI Number |
CTRI/2024/07/071425 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| 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
|
A clinical trial to assess the effect of darvi siddha tail in Reducing Symptoms of Cracked Nipples in Breastfeeding Women |
|
Scientific Title of Study
|
A randomised controlled clinical trial to study the effect of darvi siddha tail in stanachuchuka vrana in 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 Pooja Prabhakar Chougule |
| Designation |
PG student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasuti Tantra Evum Striroga SMBT Ayurved College and Hospital Dhamangaon Nashik
Nashik
Maharashtra
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
7083858576 |
| Fax |
|
| Email |
poojachougule2121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Subhash Patil |
| Designation |
Associate professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasuti Tantra Evum Striroga SMBT Ayurved College and Hospital Dhamangaon Nashik
Nashik
Maharashtra
422403
India
Department of Prasuti Tantra Evum Striroga SMBT ayurved college and hospital
Dhamangaon Nashik
Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9923601819 |
| Fax |
|
| Email |
drpp210@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Prabhakar Chougule |
| Designation |
PG student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasuti Tantra Evum Striroga SMBT Ayurved College and Hospital Dhamangaon Nashik
Nashik
Maharashtra
422403
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
7083858576 |
| Fax |
|
| Email |
poojachougule2121@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of prasuti tantra evum striroga SMBT ayurved college and hospital Dhamangaon Nashik 422403
India |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Prabhakar Chougule |
| Address |
Department of Prasuti Tantra Evum Striroga SMBT Ayurved College and Hospital Dhamangaon Nashik
Nashik
422403
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 Pooja Prabhakar Chougule |
SMBT ayurved college and hospital |
OPD no.4 department of Prasuti Tantra Evum Striroga SMBT Ayurved College and Hospital Dhamangaon Nashik
Nashik
Maharashtra
Nashik
MAHARASHTRA |
7083858576
poojachougule2121@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 | Drug | Classical | | (1) Medicine Name: Darvi siddha tail, Reference: Chakradatta chp.44 /91-92, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: After breastfeeding session | | 2 | Comparator Arm (Non Ayurveda) | | - | Nipcare ointment | It contains lanolin
Procedure - use after breastfeeding session and before each breastfeeding session wipe out the area with lukewarm water for 7days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
The signs and symptoms of stanachuchuka vrana like cracked nipple, nipple pain during breastfeeding, irritation of nipples, redness .
Postnatal mothers with the age of 18-35 years |
|
| ExclusionCriteria |
| Details |
Mastitis
Breast abscess
Congenital deformity like nipple inversion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of stanachuchuka vrana after application of darvi siddha tail |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| When the trial group stands in comparison with control group |
18 months |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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
|
The prevalence rate of cracked nipple in breastfeeding during postpartum period is 32% . In modern science treatment of cracked nipple is lanolin cream, corticosteroid creams which has its own side effects. Use of these creams for long term causes thinning of skin, skin burning, stinging, irritation, baby’s mouth develops sores or redness. In ayurvedic text convenient external medication like ghrita, tail applications are mentioned which are non invasive and effective. Darvi siddha tail has properties like vranashodhaka and vranaropaka, drugs are easily available and cost effective and has more efficient properties to heal stanachuchuka vrana.Since no work has been done on Darvi Siddha Tail in stanachuchuka vrana i.e cracked nipples in sutikavastha and no comparative has been conducted out.So it will help to fill knowledge gap . Including the married female patient having sign and symptoms of stanachuchuka vrana like stanachuchuka shula, rukshatva between age group of 18-35 year who fulfill clinical diagnostic criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Sample size calculated is 35 each group by using formula by Daniel 1999. Simple random sampling technique will be used. Total 70 number of patients will be divided in two group named as Group A (trial group and Group B (control group). Darvi siddha tail for topical application to group A (Trial group), Nipcare ointment for topical application to group B (control group) will be given to patients. Drugs will be purchased from GMC certified pharmacy. Both drugs will be administered for 7 days. All SOP of tail preparation and drug application procedure will be followed throughout the clinical trial. Observation will be done on Oth and 7th day of treatment. Result will be drawn on basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observation and result obtained during treatment. Summary will be drawn, and thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn out. |