Clinical evaluation of siddha medicine Muppirandai chooranam for heavy menstrual bleeding.

Phase 2

Not yet recruiting

Conditions: Excessive and frequent menstruation with irregular cycle,

Registration Number: CTRI/2022/11/047297

Lead Sponsor: Dr R SHANTHINI

Brief Summary: HMB or menorrhagia is the most common complaint among AUB.It is generally caused by conditions affecting the uterus or its vascularity, rather than disturbances in Hypothalamic - Pituitary - Ovarian (H-P-O) axis. Symptoms of HMB may include, bleeding through one or more pads or tampons every one or two hours, passing blood clots larger than the size of quarters, bleeding that often lasts longer than eight days, Inability to perform regular daily activities because of the bleeding. Menorrhagia affects up to 30% of women in their reproductive period. Over 5% of women ages between 30-49 years consult gynaecologist each year with this complaint. Thus, in Siddha system of Medicine, there are unique combination of medicines, which have solution to the present scenario of excessive or prolonged menstrual bleeding. One such combination is MUPPIRANDAI CHOORANAM which will be cost effective and reliable.

The aim of the study is the management of PITHA PERUMBADU (MENORRHAGIA) with siddha medicine MUPPIRANDAI CHOORANAM and the objective is to determine the therapeutic efficacy and safety profile of the siddha medicine MUPPIRANDAI CHOORANAM in the management of PITHA PERUMBADU (MENORRHAGIA).

As the literary evidences support the usage of medicine, in the disease, hypothesis is created such a way that the efficacy of MUPPIRANDAI CHOORANAM will be a better solution for PITHA PERUMBADU (MENORRHAGIA).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 40

Inclusion Criteria

Excessive menstruation (Bleeding.
one or more pads or tampons every 2 hours) Prolonged menstruation (Bleeding.
lasts longer than eight days)Puberty menstruation Premenopausal menorrhagia Menorrhagia in PCOD Hb level above 8gms.

Exclusion Criteria

Fibroid polyp Bleeding disorders Hypothyroidism Abortion and pregnancy Ovarian feminizing tumour Adenomyosis Chocolate cyst Uterine fibroids Endometrial cancer Uterine sarcomas.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduced amount of Menstrual blood flow is assessed by number of sanitary pads used before and after treatment by the chart PICTORIAL BLOOD ASSESSMENT CHARTS (PBAC)	The outcome will be assessed by reduction in the clinical symptoms for 3 consecutive cycles.

Secondary Outcome Measures

Name	Time	Method
Improvement in Hb will be monitored	Improvement of Hb will be monitored in the fourth consecutive cycle.

Trial Locations

Locations (1): Arignar anna govt hospital of indian medicine and homeopathy attached with GSMC
🇮🇳
Chennai, TAMIL NADU, India
Arignar anna govt hospital of indian medicine and homeopathy attached with GSMC
🇮🇳Chennai, TAMIL NADU, India
Dr R Shanthini
Principal investigator
7299320319
shanthinishrinky@gmail.com