| CTRI Number |
CTRI/2021/11/037954 [Registered on: 11/11/2021] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY OF INDRAVARUNI MALHAR (OINTMENT) IN THE TREATMENT OF BREAST ENGORGEMENT (STANASHOTHA) IN SUTIKA (POST- NATAL) |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF INDRAVARUNI MALHAR (OINTMENT) IN BREAST ENGORGEMENT (STANASHOTHA) IN SUTIKA (POST-NATAL) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SONALI SAMPAT GHORPADE |
| Designation |
PG SCHOLAR STREE ROG EVUM PRASUTI TANTRA |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 2 AND IPD NO 1 STREE ROG EVUM PRASUTI TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVEDA AND RESEARCH CENTRE PIMPRI PUNE 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9604461000 |
| Fax |
|
| Email |
sonalighorpade01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SMRITIKA MOHANRAO TAWARE |
| Designation |
READER |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 2 AND IPD NO 1 STREE ROG EVUM PRASUTI TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVEDA AND RESEARCH CENTRE PIMPRI PUNE 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9850967067 |
| Fax |
|
| Email |
bhonsalesmritika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SMRITIKA MOHANRAO TAWARE |
| Designation |
READER |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 2 AND IPD NO 1 STREE ROG EVUM PRASUTI TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVEDA AND RESEARCH CENTRE PIMPRI PUNE 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9850967067 |
| Fax |
|
| Email |
bhonsalesmritika@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D Y PATIL COLLEGE OF AYURVEDA AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
DR SONALI SAMPAT GHORPADE |
| Address |
OPD NO 2 STREE ROG EVUM PRASUTI TANTRA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVEDA AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Type of Sponsor |
Other [DR SONALI SAMPAT GHORPADE (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 SONALI SAMPAT GHORPADE |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
OPD NO 2 GROUND FLOOR AND IPD NO 1 FRIST FLOOR STREE ROG AVAM PRASUTI TANTRA DEPARTMENT
Pune
MAHARASHTRA |
9604461000
sonalighorpade01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O922||Other and unspecified disorders ofbreast associated with pregnancy and the puerperium. Ayurveda Condition: STANYAVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: INDRAVARUNI MALHAR, Reference: BHASHAJYARATNAVALI STANAROG CHIKITSA 70/10, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 6 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: INDRAVARUNI MALHAR, Reference: BHASHAJYARATNAVALI STANAROG CHIKITSA 70/10, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 6 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) LACTATING MOTHER FROM 1 TO 45 DAY AFTER DELIVERY
2) FULL TERM NORMAL DELIVERY AND LOWER SEGMENT CAESAREAN SECTION WHO IS SUFFERING FROM SYMPTOMS SUCH AS HEAVINESS(GURUTA), SWELLING(SHOTHA), TENDERNESS(SPARSHASAHATVA) IN BREAST
|
|
| ExclusionCriteria |
| Details |
1) ANTENATAL PATIENTS
2) PATIENTS HAVING HISTORY OF , OR CURRENTLY SUFFERING FROM ANY MALIGNANCY
3) FIBROCYSTIC CHANGES
4) BREAST LUMPS
5) BREAST ABCESS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO OBSERVE THE EFFICACY OF INDRAVARUNI MALHAR(OINTMENT) IN SWELLING (SHOTHA) ,PAIN(SHOOL),TENDERNESS(SPARSHASAHATVA), REDNESS(AARAKTAVARNA) IN BREAST ENGORGEMENT(STANASHOTHA) |
INDRAVARUNI MALHAR(OINTMENT) WILL BE GIVEN FOR LOCAL APPLICATION FOR 6 DAYS
FOLLOW UPS WILL BE ON 2ND 4TH 6TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO DO THE ANALYTICAL STUDY OF INDRAVARUNI MALHAR
TO OBSERVE THE ADVERSE EFFECT OF INDRAVARUNI MALHAR IN BREAST ENGORGEMENT |
INDRAVARUNI MALHAR(OINTMENT) WILL BE GIVEN FOR LOCAL APPLICATION FOR 6 DAYS
FOLLOW UPS WILL BE ON 2ND 4TH 6TH DAY |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS A SINGLE ARM CLINICAL STUDY IN WHICH MEDICINE INDRAVARUNI MALHAR(OINTMENT) WILL BE PROVIDED TO 40 PATIENTS SHOWING CLASSICAL SIGN AND SYMPTOMS OF STANASHOTH (BREAST ENGORGEMENT) FOR RELIEVING SYMPTOMS. THE PATIENTS WILL BE TAKEN FROM 1ST TO 45TH DAY AFTER DELIVERY( LACTATING MOTHER) . THE OINTMENT WILL BE APPLIED THRICE A DAY. AND FOLLOW UP WILL BE TAKEN ON 2ND, 4TH AND 6TH DAY. THIS CASE STUDY WILL BE OF 6 DAYS. |