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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 Shiyāf 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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  Shiyāf (suppository per vaginum) of Gond-e-babul (Acacia arabica Linn) with Kafoor (Cinnamomum campora Linn)   Shiyāf 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 Shiyāf  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 Shiyāf  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. 

 
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