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CTRI Number  CTRI/2025/12/099612 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
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 unani drug in Comparison to Tranexamic Acid in Heavy Menstrual Bleeding 
Scientific Title of Study   Efficacy of Mazoo Versus Tranexamic Acid in Heavy Menstrual Bleeding: A Randomized Standard Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hiba Fatima 
Designation  PG SCHOLAR 
Affiliation  National Institute Of Unani Medicine 
Address  Room no 29 National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9149383697  
Fax    
Email  Hibafatima935@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ismath Shameem  
Designation  Professor and HoD 
Affiliation  National Institute Of Unani Medicine 
Address  Room no 29 National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9449977008  
Fax    
Email  dr.ismaths@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Ismath Shameem  
Designation  Professor and HoD 
Affiliation  National Institute Of Unani Medicine 
Address  Room no 29 National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9449977008  
Fax    
Email  dr.ismaths@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Unani Medicine Kottigepalya main magadi road banalore 560091 Karnataka India  
 
Primary Sponsor  
Name  National Institute Of Unani Medicine 
Address  National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru 560091 India 
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 
DR Hiba Fatima  OPD 29 Ilmul Qabalat Wa Amraze e Niswan  National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA 
9149383697

Hibafatima935@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the IEC of the Institutional Ethics Com  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 500mg thrice daily will be given for the same duration will be given orally for 5 days 
Intervention  Unani formulation Mazoo (Quercus infectoria. Olive) 5g  Mazoo (Quercus Infectoria Olive) will be pounded, sieved and mixed well to make a homogenous powder, and will be administered orally in capsule form (1 capsule= 500mg) thrice daily from D1-D5 of menstruation. will be given orally. for 5 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Participants in the age group of 18-45 years with regular cycles (21-35 days) with (DOB)more than7 days and PBAC scores more than 100 for 2 out of 3 consecutive cycles.
Participants with thickened endometrium up to 18 mm adenomyosis uterine fibroids less than 3 in number and less than 3 cm in size
Participants with mild (Hb levels 11-11.9g/dL) to moderate (Hb levels 8 to 10.9.9g/dL) anemia
 
 
ExclusionCriteria 
Details  K/C/O HTN DM and hypothyroidism.
Bleeding disorders severe anemia (Hb less than 8gm) and malignancy.
Hormonal contraceptives in last 3 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in PBAC score and DOB.  Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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/ Phase 3 
Date of First Enrollment (India)   31/01/2026 
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   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 defined as menstruation that occurs at regular intervals but is characterized by excessive blood loss exceeding 80 mL per cycle or lasting more than seven days. ¹ HMB adversely affects women’s quality of life by interfering with their daily routines, work performance, lifestyle, and social engagements.  According to estimates by the World Health Organization (WHO) approximately 18 million women globally suffer from HMB. Throughout their reproductive years, about 10%–35% of women seek medical consultation for symptoms of HMB,with 5% requiring active medical intervention. In developing countries, the reported prevalence of HMB ranges between 8% and 27%.

In conventional medicine, a wide variety of treatments have been suggested for HMB including oral contraceptive pills, progestin-containing intrauterine contraceptive devices (IUCDs), nonsteroidal anti-inflammatory drugs (NSAIDs), tranexamic acid, Gonadotrophin releasing hormone (GnRH) agonist, and surgical options include endometrial ablation, dilatation and curettage, uterine artery embolization (UAE) and hysterectomy.However, these therapies may cause adverse effects such as gastrointestinal discomfort, hepatic dysfunction, weight gain, and thromboembolic events. Hypoestrogenic side effects of hormonal treatments can lead to rapid bone resorption and menopausal-like symptoms including vaginal dryness and hot flushes, further compromising the quality of life.

In conventional medicine a wide variety of treatments have been suggested for HMB including oral contraceptive pills, progestin-containing intrauterine contraceptive devices (IUCDs), nonsteroidal anti-inflammatory drugs (NSAIDs), tranexamic acid, Gonadotrophin releasing hormone (GnRH) agonist and surgical options include endometrial ablation, dilatation and curettage, uterine artery embolization (UAE) and hysterectomy.However, these therapies may cause adverse effects such as gastrointestinal discomfort, hepatic dysfunction, weight gain, and thromboembolic events. Hypoestrogenic side effects of hormonal treatments can lead to rapid bone resorption and menopausal-like symptoms, including vaginal dryness and hot flushes, further compromising the quality of life. As a result, there is a growing need for safer, well- tolerated, and effective alternative treatments especially those derived from medicinal plants, which continue to play a significant role in traditional healthcare systems.

 In recent decades, there has been an increasing global inclination toward the use of complementary and herbal medicines for the management of chronic conditions. Herbal medicine, a key component of traditional medical systems, is gaining popularity due to the widespread belief in the efficacy and safety of medicinal plants in conditions like HMB. Classical Unani literature describes several single drugs with proven efficacy in managing HMB, including Habbul Aas, Gulnar, Dammul Akhwayn, Kahruba, Gil-e-Makhtoom, and Mazoo.Among these, Mazoo (Quercus infectoria, gall oak) has been selected to evaluate its efficacy scientifically in patients with HMB due to its multiple therapeutic properties, such as Habis (styptic), Qabid (astringent), Muqawwi (tonic), Mujaffif (desiccant), Mundamil Qarih (wound-healing), and Mohallil-e-Waram (anti- inflammatory)

 
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