A STUDY OF INDRAVARUNI MALHAR (OINTMENT) IN THE TREATMENT OF BREAST ENGORGEMENT (STANASHOTHA) IN SUTIKA (POST- NATAL)

Phase 2/3

Not yet recruiting

• Conditions: Other and unspecified disorders ofbreast associated with pregnancy and the puerperium. Ayurveda Condition: STANYAVRUDDHIH,

• Registration Number: CTRI/2021/11/037954
• Lead Sponsor: DR SONALI SAMPAT GHORPADE

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-10-26
• Study Start: 2022-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

1. ANTENATAL PATIENTS 2) PATIENTS HAVING HISTORY OF , OR CURRENTLY SUFFERING FROM ANY MALIGNANCY 3) FIBROCYSTIC CHANGES 4) BREAST LUMPS 5) BREAST ABCESS.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
TO DO THE ANALYTICAL STUDY OF INDRAVARUNI MALHAR	TO OBSERVE THE ADVERSE EFFECT OF INDRAVARUNI MALHAR IN BREAST ENGORGEMENT

Trial Locations

Locations (1)

DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18; 🇮🇳 Pune, MAHARASHTRA, India

DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18

🇮🇳Pune, MAHARASHTRA, India

DR SONALI SAMPAT GHORPADE

Principal investigator

9604461000

sonalighorpade01@gmail.com