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CTRI Number  CTRI/2024/11/076920 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   research on heavy menstrual flow 
Scientific Title of Study   A Randomized Comparative Study of SafÅ«f Ḥābis and Ḥijāma bilā Shará¹­ Versus Placebo and Ḥijāma bilā Shará¹­ in Kathrat-i-Hayd (Heavy Menstrual Bleeding) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SABA ANJUM QUADRI  
Designation  PG SCHOLAR 
Affiliation  Government Unani Medical College and Hospital  
Address  Room no G6, Department of Ilmul Qabalath wa Amraze Niswan, Government Unani Medical College and Hospital Basaweshwaranagar

Bangalore
KARNATAKA
560079
India 
Phone  7411758684  
Fax    
Email  sabaanju1234@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aisha Anjum A 
Designation  Professor and HOD 
Affiliation  Government Unani Medical College and Hospital 
Address  Room no G6, Department of Ilmul Qabalath wa Amraze Niswan, Government Unani Medical College and Hospital Basaweshwaranagar

Bangalore
KARNATAKA
560079
India 
Phone  8951592300  
Fax    
Email  dr.aanjuma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aisha Anjum A 
Designation  Professor and HOD 
Affiliation  Government Unani Medical College and Hospital 
Address  Room no G6, Department of Ilmul Qabalath wa Amraze Niswan, Government Unani Medical College and Hospital Basaweshwaranagar

Bangalore
KARNATAKA
560079
India 
Phone  8951592300  
Fax    
Email  dr.aanjuma@gmail.com  
 
Source of Monetary or Material Support  
Government Unani Medical College & Hospital Bangalore 560079 
 
Primary Sponsor  
Name  Government Unani Medical College & Hospital Bangalore-560079 
Address  Government Unani Medical College and Hospital Dr Siddaiah Puranik Road, Basaveshwaranagar Bangalore-560079 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SABA ANJUM QUADRI   Government Unani Medical College and Hospital  Room no G6, Department of Ilmul Qabalat was Amraze niswan,Dr Siddaiah Puranik Road, Basaveshwaranagar Bangalore-560079 Bangalore KARNATAKA
Bangalore
KARNATAKA 
7411758684

sabaanju1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC) for Biomedical Research Government Unani Medical College Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo and Ḥijāma bilā Shará¹­ (Dry Cupping)  6g of placebo will be administered orally in the morning for 5 days i.e., from D1 to D5 of the menstrual cycle for 3 consecutive cycles. Ḥijāma bilā Shará¹­ (Dry Cupping): One cup with a size of 6.6cm (external diameter) will be applied below each breast for 10 minutes only once for 5 days i.e., from Day 1 to Day 5 of the menstrual cycle for 3 consecutive cycles.  
Intervention  SafÅ«f Ḥābis and Ḥijāma bilā Shará¹­ (Dry Cupping)  6g of SafÅ«f Ḥābis will be administered orally in the morning for 5 days i.e., from D1 to D5 of the menstrual cycle for 3 consecutive cycles. Ḥijāma bilā Shart: One cup with a size of 6.6cm (external diameter) will be applied below each breast for 10 minutes only once for 5 days i.e., from D1 to D5 of the menstrual cycle for 3 consecutive cycles.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Pictorial Blood loss Assessment Chart PBAC  Before and after menstruation for 3 months
One follow up in subsequent cycle
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Menorrhagia Questionnaire scale for quality of life
Change in Hb

 
Before and after menstruation for 3 months with 1 post follow up
Hb before and after treatment
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In Unani System of Medicine, Heavy Menstrual Bleeding is termed as Kathrat-i-Tamth/ Kathrat-i-Hayd /Khun-i-Hayd /Ifrāṭ 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 Māsika or increase in  Quwwat Dāfi‘a, Imbalance in Akhlāṭ -i- Salāsa,  BawāsÄ«r al- RahÌ£im (uterine polyps), Qurūḥ al-Rahim (uterine ulcer), Nawāṣīr  (fissure) and Saraṭān -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 Ḥābis 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 Ḥijāma bilā Shará¹­ (Dry Cupping) has been selected to validate and compare the efficacy of SafÅ«f Ḥābis. Ḥijāma bilā 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 (Mushārakat).

          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. 
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