A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF INDRAVARUNI MALHAR (OINTMENT) IN BREAST ENGORGEMENT (STANASHOTHA) IN SUTIKA (POST-NATAL)

DR SONALI SAMPAT GHORPADE1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2022年1月1日最近更新: 2021年10月26日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方
入组人数: 40
试验地点: 1
主要终点: TO OBSERVE THE EFFICACY OF INDRAVARUNI MALHAR(OINTMENT) IN SWELLING (SHOTHA) ,PAIN(SHOOL),TENDERNESS(SPARSHASAHATVA), REDNESS(AARAKTAVARNA) IN BREAST ENGORGEMENT(STANASHOTHA)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 35.00 Year(s)（—）
性别: Female

入选标准

•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.

排除标准

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

结局指标

主要结局

TO OBSERVE THE EFFICACY OF INDRAVARUNI MALHAR(OINTMENT) IN SWELLING (SHOTHA) ,PAIN(SHOOL),TENDERNESS(SPARSHASAHATVA), REDNESS(AARAKTAVARNA) IN BREAST ENGORGEMENT(STANASHOTHA)

时间窗: INDRAVARUNI MALHAR(OINTMENT) WILL BE GIVEN FOR LOCAL APPLICATION FOR 6 DAYS | FOLLOW UPS WILL BE ON 2ND 4TH 6TH DAY

次要结局

TO DO THE ANALYTICAL STUDY OF INDRAVARUNI MALHAR(TO OBSERVE THE ADVERSE EFFECT OF INDRAVARUNI MALHAR IN BREAST ENGORGEMENT)

研究者

发起方

DR SONALI SAMPAT GHORPADE

申办方类型

Other [DR SONALI SAMPAT GHORPADE (SELF)]

研究点 (1)

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