Clinical validation study to evaluate the efficacy and safety of Unani pharmacopoeial formulation-Majun Zanjabeel in Kasrat-e-Tams(Heavy Menstrual Bleeding)
Completed
- Conditions
- Abnormal uterine and vaginal bleeding, unspecified,
- Registration Number
- CTRI/2021/05/033350
- Lead Sponsor
- Central Council for Research in Unani Medicine
- Brief Summary
This is an Open label single arm clinical study which will be done in Regional Institute for Unani Medicine Srinagar in which the efficacy and safety of Unani Pharmacopeial formulation Majun Zanjabeel will be assessed in patients of Kasrat e tams (heavy menstrual bleeding)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 110
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in blood loss during the menstural cycle . patients will be assessed at 4 weeks followed by 8 weeks and 12 weeks
- Secondary Outcome Measures
Name Time Method safety of drug in terms of vital and laboratory parameters 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
Trial Locations
- Locations (1)
Regional Research Institute of Unani Medicine
🇮🇳JAMMU, & KASHMIR, India
Regional Research Institute of Unani Medicine🇮🇳JAMMU, & KASHMIR, IndiaDr Arjumand ShahPrincipal investigator7006180746dr.arjumandshah111@gmail.com