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Clinical trial for Fibroid Uterus

Multi -centric Single arm prospective open trial to check the safety and efficacy of a classical Siddha formulation Rasagandhi Mezhugu in Karuppai Narthasai Kattigal (Fibroid Uterus) among women (25-45 years) attending CCRS research institutes/unit (MERRYFUL) - MERRYFUL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020927
Enrollment
120
Registered
2019-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N719- Inflammatory disease of uterus, unspecified Health Condition 2: N719- Inflammatory disease of uterus, unspecified

Interventions

Intervention1: Rasagandhimezhugu: 500mg twice a day After food with palmjaggery for 45 days,followed by drug holiday 15 days .Again repeated for 45 days. Control Intervention1: nil: not applicable

Sponsors

Central Council for research in Siddha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: fibroid size 1 to 8cm,irrespective location of fibroid Presence of fibroid confirmed by Ultrasonogram Symptomatic and Asymptomatic patientswill be included Ambulatory and co-operative Willing to give consent to participate in the trial

Exclusion criteria

Exclusion criteria: Any previous surgical intervention underwent for fibroid subjects with cervical malignancy diagnosed with papsmear Subjects with known malignancy in any part of the body Metabolic disorders like Diabetes,Liver disorders,chronic liver conditions like Liver failure,Renal failure,jaundice etc., Vulnerable patients like HIV Pregnancy,Lactating mothers,Planning for pregnancy Not willing to give consent to participate in the trial

Design outcomes

Primary

MeasureTime frame
Reduction of size of fibroid and changes in clinical symptom from the baselineTimepoint: at baseline,at the end of 3rd month and at the end of 9th month

Secondary

MeasureTime frame
Adverse effects, drug compliance, recurrence of fibroidTimepoint: From the baseline,at the end of three months and at the end of 9 months.

Countries

India

Contacts

Public ContactShyamala Rajkumar

Siddha Central Research Institute

shyamalasiddha@gmail.com9884321221

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026