An open label single arm clinical trial to evaluate the effect of Naarikela pushpaadi kashaya in Asrugdara (Dysfunctional Uterine Bleeding)

Phase 3

Recruiting

• Conditions: Diseases of the genitourinary system, (2) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle, (3) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,

• Registration Number: CTRI/2021/02/031560
• Lead Sponsor: SDM college of Ayurveda and hospital Hassan

Brief Summary

It is an open label single arm clinical trial to evaluate the effect of Naarikela pushpaadi kashaya in Asrugdara ( Dysfunctional Uterine Bleeding).A minimum of 30 patients who are fulfilling the diagnostic and inclusion criteria will be selected from outpatient and inpatient department of prasuti tantra and striroga  SDM college of Ayurveda and hospital Hassan.A screening form will be prepared with all aspects of history, signs and symptoms of Asrugdara and laboratory investigations to rule out major illnesses.During this process patients will be thoroughly screened for signs and symptoms of Asrugdara.Naarikela pushpaadi kashaya which is mentioned in sahasrayogam in the name of Thenginpookkuladi kashaya will be administered in the dose of 25 ml twice daily ,half an hour before food diluted with equal quantity of lukewarm water for two consecutive menstrual cycles.Required drugs will be collected from south India and authenticate after taxonomical identification and will be prepared in the teaching pharmacy of SDM college of Ayurveda and hospital.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-03
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

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

Inclusion Criteria

Subject with menstral bleeding for more than 5 days in each cycle Patient using more than 3 completely soaked pads per day Intermenstrual bleeding Subjects with signs and symptoms of Asrugdara for at least 3 months.

Exclusion Criteria

Known case of threatened or incomplete abortion Known case of coagulation and bleeding disorders Known case of thyroid dysfunction Known case of sexually transmitted diseases Using intra Uterine and oral contraceptives Known case of benign and malignant growth in uterus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of symptoms such as excessive bleeding,prolonged bleeding,intermenstural bleeding,clotsAfter 2 months intervention (8 weeks)	After 2 months intervention-1 month follow up
Assessment will be done.	After 2 months intervention-1 month follow up

Secondary Outcome Measures

Name	Time	Method
Attainment of Regular menstruation	3months

Trial Locations

Locations (1)

SDM college of Ayurveda And Hospital,BM road, thanniruhalla, Hassan; 🇮🇳 Hassan, KARNATAKA, India

SDM college of Ayurveda And Hospital,BM road, thanniruhalla, Hassan

🇮🇳Hassan, KARNATAKA, India

Dr Reshma

Principal investigator

9400510383

drreshmaayu@gmail.com