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Clinical validation study to evaluate the efficacy and safety of Unani pharmacopoeial formulation-Majun Zanjabeel in Kasrat-e-Tams(Heavy Menstrual Bleeding)

open label,single arm clinical study to evaluate the efficacy and safety of unani pharmacopoeial formulation -Majun Zanjabeel in kasrat-e-Tams(Heavy menstrual Bleeding)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033350
Enrollment
110
Registered
2021-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: - Health Condition 2: N939- Abnormal uterine and vaginal bleeding, unspecified

Interventions

Intervention1: Majun Zanjabeel: 5gm two times a day given orally for 12 weeks (given only for 9 days each month starting from day 1 of menstrual cycle for three consuctive cycles) Intervention2: Majun

Sponsors

Central Council for Research in Unani Medicine
Lead Sponsor
Central Council for Research in Unani Medicine
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Non Gravid females of reproductive age patients with menorrhagia as indicated by i) Excessive menstrual loss greater than 80 ml per cycle as calculated by menstrual pictogram ii) Menstrual cycle greater than 6 days

Exclusion criteria

Exclusion criteria: 1. Heavy Menstrual Bleeding with structural or histological abnormality with symptoms such as Intermenstrual or post coital bleeding pelvic pain and or pressure symptoms 2. Patients presenting with Heavy Menstrual Bleeding since menoarche • Patients with a personal or family history suggesting a coagulation disorder • Patients using Intrauterine Contraceptive Devices • Patients with illness requiring long term treatment e.g Hypertension TB etc • Patients with Post-menopausal bleeding • Patients with HMB taking Hormone Replacement Therapy • Conditions where HBM is not the main presenting menstrual symptom eg endometriosis • Pregnant and lactating females

Design outcomes

Primary

MeasureTime frame
Decrease in blood loss during the menstural cycle .Timepoint: patients will be assessed at 4 weeks followed by 8 weeks and 12 weeks—

Secondary

MeasureTime frame
safety of drug in terms of vital and laboratory parametersTimepoint: for vitals the patients will be assessed at baseline followed by 4 weeks 8 week and 12 week whereas, for laboratory parameters patients will be assessed at baseline and at 12 week of the study—

Countries

India

Contacts

Public ContactTowseef Amin rafeeqi

Regional research Institute of Unani Medicine ,Srinagar(CCRUM Ministry of AYUSH)

dr.arjumandshah111@gmail.com7006180746

Outcome results

None listed

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