Efficacy of Zaj in Kathrat-i-Hayd (Heavy Menstrual Bleeding) -A Randomized Comparative Clinical Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change in Pictorial Blood Loss Assessment Chart PBAC
Study Overview
Brief Summary
Kathrat i Hayd Heavy Menstrual Bleeding may be defined as prolonged or heavy cyclic menstruation. Objectively menses lasting longer than 7days or exceeding 80ml of blood loss are the determining values. Heavy menstrual bleeding or excessive menstrual blood loss can seriously affect the quality of life of women since it interferes with the physical, emotional, social and material quality of life. HMB prevalence in women varies between 27.2 percentage and 54.0 percentage, making it a common disorder. HMB has been shown to have negative effects on the psychological state, energy, work productivity, social relationships, family life and sexual functions of women.
According to the classical Unani literature, Kathrat i Hayd is defined as cyclical bleeding which may be excessive in amount or duration lasting longer than 7 days. Istehaza is a condition in which the cycles are irregular with excessive bleeding and the duration is longer.
Medical treatment for HMB includes a wide variety comprising of non hormonal tranexamic acid, NSAIDs, hormonal LNG-IUS, combined hormonal contraception, cyclical oral progestogens and surgical management includes myomectomy, hysterectomy. Heavy Menstrual Bleeding HMB significantly affects womens quality of life. It is essential to prioritize interventions that enhance overall quality of life rather than merely reducing blood loss.
Unani medicine offers safe and effective treatment for HMB in various forms including oral single or compound form and or local vaginal pessary, vaginal suppository, sitz bath. After through Unani literature, Hamil of Zaj Alum has been selected for the clinical trial as it has properties like Habis i Dam haemostatic and Qabid astringent . Hence, this clinical study is planned to determine and compare the efficacy of Zaj suppository per Rectum vs per Vaginam in women with HMB.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Married women between the age group of 18 to 45yrs.
- •2.Study participants having regular cycles with increase in amount of blood flow more than 80ml, duration of flow more than 7days or both.
- •3.Study participants with pelvic pathology like uterine fibroid less than 3cms single or multiple and adenomyosis.
- •4.PBAC score 100 to 500 5.Study participants with HB percentage more than 7gms percentage.
Exclusion Criteria
- •1.Study participants with Hb percentage below 7gm percentage.
- •2.Study participants with uncontrolled diabetes mellitus RBS more than 200mg per dl and thyroid dysfunction more than 5.0mlU per L 3.Study participants with blood dyscrasias and malignancy.
- •4.Study participants on OCPs and other hormonal therapy.
Outcomes
Primary Outcomes
Change in Pictorial Blood Loss Assessment Chart PBAC
Time Frame: Every follow up
Secondary Outcomes
- 1.Change in SF 12 scale for Quality of life(2.Change in Hb percentage level)
Investigators
Dr Humera Sadiya
Government Unani Medical College and Hospital
