| CTRI Number |
CTRI/2020/02/023357 [Registered on: 14/02/2020] Trial Registered Prospectively |
| Last Modified On: |
11/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Unani treatment for Heavy Menstrual Bleeding |
|
Scientific Title of Study
|
Effect of Qurs-i-Shibb in Kathrat-i-Tamth (HMB): An observational clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ghufrannajeeb@gmail.com |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ghufran Najeeb |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD
Bangalore
KARNATAKA
560091
India |
| Phone |
9575208964 |
| Fax |
|
| Email |
ghufrannajeeb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Wajeeha Begum |
| Designation |
Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD
Bangalore
KARNATAKA
560091
India |
| Phone |
9972550185 |
| Fax |
|
| Email |
drwajeehanium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ghufran Najeeb |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicin |
| Address |
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGEPALYA, MAGADI MAIN ROAD
Bangalore
KARNATAKA
560091
India |
| Phone |
9575208964 |
| Fax |
|
| Email |
ghufrannajeeb@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
NATIONAL INSTITUTE OF UNANI MEDICINE,
KOTTIGE PALYA, MAGADI MAIN ROAD.
Bangalore-560091 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ghufran Najeeb |
NATIONAL INSTITUTE OF UNANI MEDICINE |
KOTTIGE PALYA, MAGADI MAIN ROAD.
Bangalore
KARNATAKA |
9575208964
ghufrannajeeb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) for Biomedical Research |
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 |
Not applicable |
Not applicable |
| Intervention |
Qurs-i-shibb |
Shibbe Yamani(Alum) 10.5 gram
Damul Akhwain Dracaena cinnabari Balf.f.) 10.5 gram
Gulnar (Punica granatum Linn.) 10.5gram
Kateera(Cochlospermum relgiosum Linn.) 21 gram
Samaghe arabi(Acacia arabicaLinn.) 7gram
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1-Women between the ages of 18-40 Years.
2-Regular cycles with heavy bleeding in duration or amount of flow or both.
|
|
| ExclusionCriteria |
| Details |
Patients with
1-Hb less than 8.5 gm%.
2-H/o systemic diseases and blood dyscrasia.
3-H/o of pelvic pathology and malignancy.
4-H/o of OCPs,IUCD insertion in last 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in Bleeding
(amount/ duration) |
One and half year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in
1-PBAC Score(100)
2-SF12 scale to assess the QoL |
One and Half year
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
19/02/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title of study: Effect of Qurs-i-Shibb in Kathrat-i-TÌ£amth (HMB): An observational clinical study.
Menorrhagia is a Greek word, derived from two words; men means menses and rrhagia means burst forth.It is generally defined as excessive bleeding, either in duration or quantity of blood loss or both (> 8 days and/or >80 ml) at regular intervals.In Unani system of medicine several single drugs such as bartang, tabasheer,shibbe yamani, khurfa, geru, sange jarahat, damul akhwain, rasaut and compound drugs are safoofe habis, majoone busd,qurse gulnar, qurse kahruba, sharbate injebar, Qurs-i-Shibb etc. are available to control heavy bleeding and are more convenient being administered and more over it is non-hormonal treatment. Among these drugs Qurs-i-Shibb is selected to evaluate its efficacy in the management of Kathrat-i-TÌ£amth.
Procedure of the study:Diagnosed cases of Kathrat-i-TÌ£amth will be informed about the study procedures and written consent will be obtained. Orally Qurs-i-Shibb two tablets will be administrated thrice daily for 5 days from day 1 of cycle for 2 cycles. Follow up of patient will be done before and after each cycle for 2 consecutive cycles during trial and one follow up after completion of trial.
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