| CTRI Number |
CTRI/2024/01/060987 [Registered on: 01/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Research on increased menstrual bleeding in Unani Medicine |
|
Scientific Title of Study
|
Comparative study of Tukhm-e -Bartang with Tranexamic acid in Kathrat-i-Tamth (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 Sumaiya Kouser |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Room no G6, Department of Ilmul Qabalath was amraze niswan,Government Unani Medical College and Hospital Basaweshwaranagar
Bangalore
KARNATAKA
560079
India |
| Phone |
9611844505 |
| Fax |
|
| Email |
sumaiyakouser98@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 was 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 was 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumaiya Kouser |
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 |
9611844505
sumaiyakouser98@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
|
|
|
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 |
| Intervention |
Safoof(powder) of Tukhm-e-Bartang |
Orally thrice daily for 5 days for 3 consecutive cycles (From D1 to D5 of menstruation) |
| Comparator Agent |
Tranexamic acid 500mg |
Orally thrice daily 5 days for 3 consecutive cycles (From D1 to D5 of menstruation) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients of reproductive age group 18- 45yrs.
Patients with regular menstrual cycle with amount of flow more than 80ml and/or duration of flow more than 7 days.
Patients with pelvic pathology like Uterine fibroids less than 3 cms and adenomyosis.
Patients with IUCD.
|
|
| ExclusionCriteria |
| Details |
Patients with (uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction).
Severe anemia with Hb% less than 7mg/dl.
Uterine fibroids more than 3cms.
Patients on OCP’S, or any other hormonal therapy.
Patients with blood dyscrasias and malignancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in menstrual pictogram score. |
Before and after mensturation for 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in SF-12 scale for quality of life.
Improvement in Hb%.
|
Before and after mensuration for 3 months. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/01/2024 |
| 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 Applicable |
| 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
|
Heavy menstrual bleeding (HMB) is defined as excessive menstrual blood loss which interferes
with a woman’s physical, social, emotional and/or material quality of life, which can occur alone or in
combination with other symptoms. It is quantitatively described as menstrual blood loss of 80 ml or more
every cycle . Heavy menstrual bleeding is one of the most common gynecological problems, the
occurrence of which increases with age. More than 30% of women of reproductive age group and 60% of
the total women population experience it.
In Unani system of medicine Kathrat-i-Tamth is described as increased menstrual blood loss either
in amount or in duration. It is mainly caused due to Su-i-Mizaj al Rahim or Duf-i-rahim. In conventional
system of medicine, a wide variety of treatment modalities are now available. First line of treatment
includes Hormonal [LNG-IUS, combined hormonal contraception, cyclic oral progestogen] and Non-hormonal (Tranexamic acid, NSAID’S). If this fails surgical intervention, is required . Hysterectomy
provides a definitive cure for heavy menstrual bleeding. However, the recent literature more often relays
on less invasive and simpler techniques that decrease morbidity and preserve fertility. The costs of HMB related surgery are high and economic burden on the patient. Hence herbal or traditional medicines
provides cost effective and risk-free treatment option.
In Unani system of medicine single drugs such as Bartang, Anjabar, Geru, Sange jarahat, Dammul
Akhwain and compound formulations like Qurs-e-kohrba, Qurs-e-kafoori, Majoon-e-busad, Safoof habis
etc. are used in the treatment of Kathrat-i-Tamth . Tukhm-e-Bartang is selected to evaluate its efficacy
in Kathrat-i-Tamth as it exhibits the properties of Habis, Qabis, Moharrik, Muaddil. Considering all the
above-mentioned facts it has been decided to conduct a comparative study of Tukhm-e-Bartang with
Tranexamic acid in Kathrat-i-Tamth (Heavy Menstrual Bleeding). |