| 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 ḤÄbis and ḤijÄma bilÄ Shará¹ Versus Placebo and ḤijÄma bilÄ 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
|
|
|
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
|
|
|
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 ḤijÄma bilÄ 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.
ḤijÄma bilÄ 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 ḤÄbis and ḤijÄma bilÄ Shará¹ (Dry Cupping) |
6g of SafÅ«f ḤÄbis will be administered orally in the morning for 5 days i.e., from D1 to D5 of the menstrual cycle for 3 consecutive cycles.
ḤijÄma bilÄ 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
|
|
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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 /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. |