Assess efficacy of Tiktaka ghrita enema & Dhtaki-Pugi kashaya in excessive uterine bleeding patients

Phase 3

Recruiting

• Conditions: Intraoperative and postprocedural complications and disorders of genitourinary system, not elsewhere classified, (2) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract,

• Registration Number: CTRI/2019/05/018981
• Lead Sponsor: Amrita School Of ayurveda

Brief Summary

open label singlearm clinical study to evaluate the effect of Tiktakaghrita matravasti & Dhataki-pugi kashaya in asrigdara (Dysfunctional Uterine Bleeding). For this study 30 patients attending the striroga & prasuti tantra OPD&IPD of  Amrita School Of Ayurveda fullfilling the inclusion criteria will be recruited for study.The primary data for inclusion will be collected using proper history taking,pictorial blood assessment chart,USG & Blood routine examination.Medicine tiktaka ghrita purchased & it is used for matravasti 72 ml followed by internal administration of 48 ml fresh Dhataki pugi kashayatwice dailyfor 7 days.Procedure will be started only after 7 th day f menstruation,if the bleeding is not controlled with other oral medication.The assessment of blood loss is done through the pictorial blood assessment chart during each day of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-05
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• 1Patients with age group 16-45 yrs.
• 2Patients complaining with excessive bleeding /Prolonged bleeding/ / intermenstrual bleeding with increased amount (>80 ml) No. of pads (>4 pads/day) & duration (> 7 days) for at least previous three consecutive cycles.

Exclusion Criteria

• 1Pregnancy & Abortion, PPH, IUCD insertion 2Hb < 9 gm% 3Known case of DM, HTN, Renal diseases, Liver Diseases, Cardiac diseases Von-Willebrand’s disease & other bleeding diseases.
• 4Known case of organic & pelvic pathology as per Ultrasonography report.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of bleeding	After 7th day of menstruation

Secondary Outcome Measures

Name	Time	Method
Number of Clots	After 7 th day of menstrual cycle

Trial Locations

Locations (1)

Amrita School Of Ayurveda; 🇮🇳 Kollam, KERALA, India

Amrita School Of Ayurveda

🇮🇳Kollam, KERALA, India

Asha Lekshmi N

Principal investigator

8304076245

lekshmiasha90@gmail.com