| 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
|
|
|
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
|
|
|
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) |