| CTRI Number |
CTRI/2021/01/030184 [Registered on: 01/01/2021] Trial Registered Prospectively |
| Last Modified On: |
16/01/2023 |
| 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
|
Effect of Babul and Kafoor pessary on heavy menstrual bleeding |
|
Scientific Title of Study
|
Effect of ShiyÄf of Gond-i-Babul and Kafoor in Kathrat-i-Hayd (Heavy Menstrual Bleeding)-A Randomized Controlled 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 |
Mohamed Joonus Aynul Fazmiya |
| Designation |
Pg scholer |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept. of Amraze Niswan wa Ilmul Qabalath. National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore
Bangalore KARNATAKA 560091 India |
| Phone |
7349796182 |
| Fax |
|
| Email |
mjafazmiya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Arshiya Sultana |
| Designation |
Reader |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept. of Amraze Niswan wa Ilmul Qabalath. National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore
Bangalore KARNATAKA 560091 India |
| Phone |
9740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Arshiya Sultana |
| Designation |
Reader |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Dept. of Amraze Niswan wa Ilmul Qabalath. National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore
KARNATAKA 560091 India |
| Phone |
9740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Kottigepalya, Bangalore |
| 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 |
| Arshiya sultana |
National Insittute of Unani Medicine |
Room No. 29, Dept of
Ilmul Qabalat wa
Amraze Niswan,
Kottigepalya, Magadi
Main Road
Bangalore
KARNATAKA Bangalore KARNATAKA |
9740915911
drarshiya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N924||Excessive bleeding in the premenopausal period, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ShiyÄf (suppository per vaginum) of Gond-e-babul (Acacia arabica Linn) with Kafoor (Cinnamomum campora Linn) |
ShiyÄf of Gond-e-Babul (3.5g) with Kafoor (3.5g) will be given 7 days from day 1 to day 7 of menstruation for 3 consecutive cycles and oral placebo capsules will be given |
| Comparator Agent |
Tranexamic acid 500mg |
Tranexamic acid 500mg BD given for 5days and locally placebo suppositories will be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women with regular cycles (21-35 days) with Kathrat-i-Hayd (heavy bleeding) in duration (more than 7 days) or amount of flow (>80 ml) or both |
|
| ExclusionCriteria |
| Details |
Pelvic pathology (uterine fibroids >3cms and/or >3 in number, polyp, PID) and malignancy
Diagnosed cases chronic renal, liver disease, uncontrolled HTN and uncontrolled DM) and endocrine diseases (thyroid dysfunction)
Bleeding disorders, severe anemia (Hb <7gm%)
H/O hormonal contraceptives in last 3 months.
Pregnant and lactating mother
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Pictorial Blood Loss Assessment Chart (PBAC) score for menstrual blood loss |
Every month for 4 months after completion of menstrual phase of menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in SF-36 HRQoL questionnaire to assess the quality of life. |
At baseline and at fourth menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/01/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Communicated for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Kathrat-i-Hayd
or Ifraat-i-Hayd means
is excessive
menstrual blood loss either in amount or duration. Heavy menstrual bleeding (HMB) or menorrhagia is
one of the most frequently encountered symptoms in gynaecology. It is defined
as menstruation periods at regular cycle but with an excessive flow which may
last more than 7 days. Menorrhagia can cause menstrual bleeding of more than 80
ml in each cycle.. Heavy menstrual bleeding (HMB) is a benign yet
debilitating social and health condition.Medical management for HMB in conventional medicine has
different side effects such as gastrointestinal symptoms, liver disease,
obesity, and thromboembolic diseases. Moreover, hypoestrogenic state as a side
effect of these therapies can lead to rapid bone demineralization and
menopausal symptoms such as vaginal dryness and hot flushes and so on, which
reduce the quality of life.Unani medicine is the oldest system that prevails till date
with its effective remedies. Shabat-i-Anjabar, Qurs-i-Habis,Gulnarb and Hijama bila Shart have
been validated and clinically proven for their effectiveness in Kathrat-i-Hayd. However, none of the
studies has evaluated the effect of ShiyÄf of Gond-e-babul (Acacia arabica
Linn) and Kafoor (Cinnamomum
campora Linn) in Kathrat-Hayd. Therefore, the objective of the present study will be to evaluate and validate the effect of ShiyÄf of Gond-i-Babul and Kafoor in Kathrat-i-Hayd
as they possess Habis wa Qabiz and Muhallil properties. The efficacy of the
test and control drug will be assessed by Pictorial Blood Loss Assessment Chart
(PBAC) score for menstrual blood loss and SF-36 HRQoL questionnaire to assess the
quality of life. |