Uterine Fibroids-Effect of Ayurvedic regimen

Phase 2

Recruiting

Brief Summary: The proposed study intended to prove and establish the efficacy of khadirarishta and kanchanara guggulu in the management of uterine fibroids with evidence based data scientifically. This study will be conducted in Ayurveda Research Institute for Mother and Child Health Care- a peripheral research institute of CCRAS. Patients are to be identified, screened and selected from ARIMCHC OPD as per criteria. The expected outcome measures are

1. Changes in clinical symptoms

2. Changes in the size of fibroids.

Total trial period of this study is 3 years and treatment duration is 6 months.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Recruitment & Eligibility

Inclusion Criteria

Symptomatic Females, 25-50 yrs Uterine fibroids, uterine size< 12 weeks, and at least one fibroid>2 cm but none>5 cm on U/S Pre menopausal ladies with Uterine Fibroids getting at least 1 menstrual period in last three months.
Normal PAP smear.

Exclusion Criteria

Pregnancy, Lactation.
Unexplained vaginal bleeding, cervical dysplasia, abnormal ovarian or adnexal mass.
History of malignancy within the past 5 years.
Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations.
Use of herbal medication having estrogenic or antiestrogenic effect within the past 3 months.
Known recent rapid growth of fibroids, defined as a doubling in size in six months.
Haemoglobin level below 8gm% Patients suffering from any other major systemic illness necessitating long term drug Therapy.

Primary Outcome Measures

Name	Time	Method
Changes in the clinical symptoms	At base line 30th day, 60th day, 90th day, 120th day, 150th day and 180th day i.e at the time of trial completion

Secondary Outcome Measures

Name	Time	Method
Changes in the size of fibroids	At the screening day, 90th day and end of the study (180th day)

Locations (1): ARIMCHC-Thiruvananthapuram
🇮🇳
Thiruvananthapuram, KERALA, India
ARIMCHC-Thiruvananthapuram
🇮🇳Thiruvananthapuram, KERALA, India
Dr S Indirakumari
Principal investigator
9446795133
arimchc.trivendrum@gmail.com