A Randomized Comparative Study of SafÅ«f ḤÄbis and ḤijÄma bilÄ Shará¹ Versus Placebo and ḤijÄma bilÄ Shará¹ in Kathrat-i-Hayd (Heavy Menstrual Bleeding)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Pictorial Blood loss Assessment Chart PBAC
Study Overview
Brief Summary
| In Unani System of Medicine, Heavy Menstrual Bleeding is termed as *Kathrat-i-Tamth/ Kathrat-i-Hayd /Khun-i-Hayd /IfrÄá¹ rawangi /Sailan-i-Hayd.*According to the classical Unani literature Heavy menstrual bleeding occurs due to Sū’i-Miẓaj- i-Rahim Sada or Maddi (deranged temperament of uterus), Weakness in Quwwat MÄsika or increase in Quwwat DÄfi‘a, Imbalance in AkhlÄá¹ -i- SalÄsa, BawÄsÄ«r al- RahÌ£im (uterine polyps), Qurūḥ al-Rahim (uterine ulcer), NawÄṣīr(fissure) and Saraá¹Än -e-unq al-Rahim wa Rahim (carcinoma of cervix and uterus) etc. which leads to weakening of uterine vessels and causes vasodilation. |
The etiology of Heavy menstrual bleeding includes hormonal, mechanical, and clotting abnormalities. Hormonal causes include: anovulation, hypothyroidism, Mechanical causes include, endometriosis, endometritis and carcinoma. Clotting abnormalities include: vitamin K deficiency and circulating inhibitors of coagulation. HMB can be associated with fibroids, endometriosis, adenomyosis, cervical or endometrial malignance, intrauterine devices or pelvic infections. Sometimes it can be caused by factors in relation to hypothyroidism or bleeding disorders. Women with Heavy bleeding are at higher risk for serious medical consequences. These women are likely to develop iron-deficiency anemia as a result of their blood loss. Excessive blood loss can cause anemia, tiredness, indigestion, decreased appetite, edema and pica.
After reviewing the literature SafÅ«f ḤÄbis consisting -Sange Jarahat, Mazu Sabz, Kaat Safaid and Maeen has been selected to conduct a clinical trial. As these ingredients are having the properties of Habis (styptic), Qabiz (astringent), Muhallil Auram (anti Inflammatory) etc.
Apart from oral treatment application of ḤijÄma bilÄ Shará¹ (Dry Cupping) has been selected to validate and compare the efficacy of SafÅ«f ḤÄbis. ḤijÄma bilÄ Shará¹ is a type of regimental therapy that is used in reducing menstrual blood flow in Kathrat-i-Hayd, which is non-invasive procedure and has no potential for drug. Large cups should be placed below the breast as vessel from the uterus to the breast reach here and get absorbed due to its special connection (MushÄrakat).
Various tools have been used for the assessment of blood loss. A Pictorial Blood -loss Assessment Chart (PBAC) is a practical and objective method that has high sensitivity and specificity when more than 100 score is accepted. For Quality-of-life Menorrhagia Questionnaire (MQ) is used.
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
- •Women both married and unmarried between the age group of 18- 45yrs Women having regular cycles with increase in amount, duration of flow more than 7days or both Patients with pelvic pathology like Uterine fibroid less than 3cms (single or multiple) and Adenomyosis PBAC score more than 100.
Exclusion Criteria
- •Patients with Hb less than 7 gm Patients with uncontrolled Diabetes mellitus RBS more than 200mgdl uncontrolled Hypertension BP more than 140/90mmHg Patients with Blood dyscrasias and Malignancy Patients on OCPs and other hormonal therapy.
Outcomes
Primary Outcomes
Change in Pictorial Blood loss Assessment Chart PBAC
Time Frame: Before and after menstruation for 3 months | One follow up in subsequent cycle
Secondary Outcomes
- Change in Menorrhagia Questionnaire scale for quality of life(Change in Hb)
Investigators
DR SABA ANJUM QUADRI
Government Unani Medical College and Hospital