| 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
|
|
|
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
|
|
|
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. |