FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/079255 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
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 Cupping and Plantain Seeds versus Tranexamic Acid in Women in women with Heavy Menstrual Bleeding. 
Scientific Title of Study   Efficacy of Hijama Bila Shart and Tukhm Bartang versus Tranexamic Acid in Women with Kathrat-i-Hayd.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Not Applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramsha Arshad 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Room No. 29, OPD, Dept. of Amraze Niswan Kottigepalya, Magadi Main Road

Bangalore
KARNATAKA
560091
India 
Phone  9109645156  
Fax    
Email  ramshaarshad21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramsha Arshad 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Room No. 29, OPD, Dept. of Amraze Niswan Kottigepalya, Magadi Main Road


KARNATAKA
560091
India 
Phone  9109645156  
Fax    
Email  ramshaarshad21@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PROF DR ARSHIYA SULTANA 
Designation  Professor  
Affiliation  National Institute of Unani Medicine  
Address  Room No. 29, OPD, Dept. of Amraze Niswan Kottigepalya, Magadi Main Road,Bengaluru-560091, Karnataka

Bangalore
KARNATAKA
560091
India 
Phone  09740915911  
Fax    
Email  drarshiya@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru, Karnataka, India 
 
Primary Sponsor  
Name  National Institute of Unani Medicine  
Address  Kottigepalya, Magadi Main Road,Bengaluru-560091, Karnataka 
Type of Sponsor  Government medical college 
 
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 
Prof Dr Arshiya Sultana  National Institute of Unani Medicine   Room No. 29, OPD, Dept. of Amraze Niswan, Kottigepalya, Magadi Main Road
Bangalore
KARNATAKA 
9740915911

drarshiya@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Unani Medicine, Institutional Ethics Committee for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Tranexamic Acid   Tranexamic Acid 500 mg TID for 5 days from first day of menstruation 
Intervention  Tukhm Bartang (Plantago major L.) and Hijama bila Shart   Tukhm Bartang will be given orally 5g will be given in three divided doses for 5 days from first day of menstruation. 2 large cups will be used below the breast for 15 minutes for 3 days from first day of menstruation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  42.00 Year(s)
Gender  Female 
Details  Study participants in the age group of 18-42 years with regular cycles (21-35 days) with MBL greater than 80 ml or DOB greater than 7 days for 2 out of 3 consecutive cycles. Study participants with PBAC scores greater than 80ml and Samanta scores more than 3. Study participants with thickened endometrium up to 18 mm, adenomyosis,uterine fibroids less than 3 in number and less than 3 cm in size. Study participants with mild (Hb levels 11-11.9g/dL) to moderate (Hb levels 8 to 10.9.9g/dL) anemia.
 
 
ExclusionCriteria 
Details  Study participants with co-morbidities such as uncontrolled hypertension (Stage 2 hypertension more than 140/90 mmHg), uncontrolled diabetes mellitus (FBS more than 130mg/dl or PPBS more than 180mg/dl or RBS more than 200mg/dl or HbA1c more than 7.00%), uncontrolled hypothyroid, Bleeding disorders, severe anaemia (Hb less than 8gm%) and malignancy. Hormonal contraceptives in last 3 months. Study participants with uterine fibroid more than 3 in number and more than 3 cm in size.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PBLAC (Pictorial Blood Loss Assessment Chart)  PBLAC (Pictorial Blood Loss Assessment Chart) will be assessed at baseline, week 4, 8, 12 and week 16 
 
Secondary Outcome  
Outcome  TimePoints 
Samanta questionnaire, MIQ (Menorrhagia Impact Questionnaire), Haemoglobin percentage  The secondary outcome Samanta & MIQ will assessed after menstruation at baseline, week 4, week 8, 12 & week 16. Haemoglobin percentage will be assessed at baseline & week 12. 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   N/A 
Date of First Enrollment (India)   03/02/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 diagnosed as excessive or prolonged uterine bleeding per menstruation of more than 80 ml or for 7 days in a normal cycle. According to the traditional Unani texts, excessive menstrual blood loss (MBL) with regular cycles and excessive bleeding, either in volume or length, are the characteristics of heavy menstrual bleeding (HMB).  An alternative semiquantitative technique for evaluating MBL makes use of a pictorial blood loss assessment chart (PBLAC). Menorrhagia can be effectively treated using a variety of herbs and regimental therapy, such as dry cupping, which is part of the Unani medical system. Plantago major, commonly known as great plantain or Tukhm Bartang in Unani medicine, belongs to the Plantaginaceae family. Tukhm Bartang has been chosen as a study drug among the various medications accessible for HMB. It possesses Syptic, detergent, Musakkin, and others.  It contains several active compounds, i.e. phenolic acids, flavonoids, tannins, polysaccharides, terpenoids, lipids, iridoid glycosides, and caffeic acid derivatives. Application of dry cupping below the breast is also useful to control heavy menstrual bleeding. The hypothesis of the study will be dry cupping and Tukhm Bartang versus tranexamic acid in HMB will be effective at post-intervention. The objective of the study is to determine and compare the efficacy of dry cupping and Tukhm Bartang versus tranexamic acid in HMB.  Diagnosed cases of HMB fulfilling the inclusion criteria will be randomly selected. Written informed consent will be obtained from patients. The drug will be given either to the test or control group. In the test group, 5g of Tukhm Bartang will be given in three divided doses for five days and dry cupping for 3 days from the first day of menstruation for 3 consecutive months. Patient global assessment of tolerability to therapy will be assessed for safety and tolerability to therapy at the end of the treatment.  PBLAC, and Samanta questionnaire will be assessed at baseline and each follow-up. MIQ (Menorrhagia Impact Questionnaire) and Haemoglobin percentage will be assessed at baseline and at the end of the intervention. The total sample will be 62 patients (31 in each group).  The Primary outcome will be assesd PBLAC (Pictorial Blood Loss Assessment Chart). The secondary outcome will be Samanta questionnaire, MIQ (Menorrhagia Impact Questionnaire), and Haemoglobin percentage. The appropriate tests will be applied to analyse the data. Descriptive statistical analysis will be used in the study. Results on continuous measurements will be presented in mean (SD) and results on the categorical measurements will be presented in number (percentage) with a 5 percent  level of significance and 95 percent confidence interval.

 
Close