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CTRI Number  CTRI/2025/12/098342 [Registered on: 02/12/2025] Trial Registered Prospectively
Last Modified On: 28/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) [Therapeutic ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Research on Heavy Menstrual flow in Unani Medicine 
Scientific Title of Study   Efficacy of Zaj in Kathrat-i-Hayd (Heavy Menstrual Bleeding) -A Randomized Comparative Clinical Study 
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 Humera Sadiya 
Designation  PG Scholar 
Affiliation  Government Unani Medical College and Hospital  
Address  Department of Ilmul Qabalat wa Amraz e Niswan Room no.11 Government Unani Medical College and Hospital Dr. Siddaiah Puranik Road Basaveshwaranagar

Bangalore
KARNATAKA
560079
India 
Phone  8095806913  
Fax    
Email  humerasadiya24@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  Department of Ilmul Qabalat wa Amraz e Niswan,Room no.11, Government Unani Medical College and Hospital Dr. Siddaiah Puranik Road, Basaveshwaranagar

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  Department of Ilmul Qabalat wa Amraz e Niswan,Room no.11, Government Unani Medical College and Hospital Dr. Siddaiah Puranik Road, Basaveshwaranagar


KARNATAKA
560079
India 
Phone  8951592300  
Fax    
Email  dr.aanjuma@gmail.com  
 
Source of Monetary or Material Support  
Government Unani Medical College and Hospital,Bangalore 560079 
 
Primary Sponsor  
Name  Government Unani Medical College and Hospital 
Address  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 Humera Sadiya  Government Unani Medical College and Hospital  OPD 11,Ilmul Qabalat wa Amraz e Niswan Government Unani Medical College and Hospital Dr. Siddaiah Puranik Road, Basaveshwaranagar
Bangalore
KARNATAKA 
8095806913

humerasadiya24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical Research, Government Unani Medical College and Hospital, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Zaj(Aluminium potassium sulphate/Potash alum suppository for Local Administration per Rectum  Zaj (1g) will be formulated as suppository along with suitable suppository base and will be inserted per rectum two times a day for three days from Day 1 to Day 3 of menses for 2 consecutive menstrual cycles. 
Comparator Agent  Zaj(Aluminium potassium sulphate/Potash alum suppository for Local Administration per Vaginam  Zaj (1g) will be formulated as suppository along with suitable suppository base and will be inserted per vaginam two times a day for three days from Day 1 to Day 3 of menses for 2 consecutive menstrual cycles. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. 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 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Pictorial Blood Loss Assessment Chart PBAC  Every follow up 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in SF 12 scale for Quality of life
2.Change in Hb percentage level 
1.Change in SF 12 scale for Quality of life Before and After treatment
2.Change in Hb percentage level Before and After treatment 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   10/12/2025 
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="6"
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  
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.
 
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