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CTRI Number  CTRI/2025/01/079496 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Effect of Unani formulations in Uterine Fibroid: A pre and post analytical study 
Scientific Title of Study   Effect of Unani formulations Oral & Topical in uterine fibroid A pre and post analytical 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  Qureshi Misbah Mohammed Husain 
Designation  PG Scholar 
Affiliation  National institute of unani medicine 
Address  Room No.29,OPD,Amraze Niswan Kottigepalya, Magadi main road
Room No.29,OPD,Amraze Niswan Kottigepalya, Magadi main road
Bangalore
KARNATAKA
560091
India 
Phone  9920226271  
Fax    
Email  misbahhl150897@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ismath Shameem 
Designation  Pofessor and HoD  
Affiliation  National institute of unani medicine 
Address  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  Pofessor and HoD  
Affiliation  National institute of unani medicine 
Address  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,Magadi Main Road,Bangalore,Karnataka,560091 
 
Primary Sponsor  
Name  National institute of Unani medicine 
Address  National institute of Unani medicine kottegepalya magadi main road bangalore 560091 
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 Misbah Qureshi Mohammed Husain  National institute of Unani medicine  Room No.29,OPD,Amraze Niswan kottigepalya, magadi main road
Bangalore
KARNATAKA 
9449977008

misbahhl150897@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Unani Medicine Bangalore Communication of decision of the Institutional ethics committee(IEC) for Biomedical research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Orally- Joshanda of Aslussoos, badiyan, badranjboya with Gulqand. Locally- Zimad of Tukhme Katan, Tukhme Hulba, Haloon and roughane bedanjeer   Oral- Aslussoos, badiyan, and badranjboya each 5g will be soaked in water in a ratio of 1:5 for 6 hours. Then it will be boiled till the water is reduced to half and filtered through a sieve. After cooling it, gulqand 5g will be added and prescribed to the patients orally twice daily in an empty stomach for 12 weeks. Locally- Zimad will be prepared from Tukhme Katan, Haloon and Tukhme Hulba, each 5g in 15ml of roughane bedanjeer and will be applied over the lower abdomen twice daily for 12 weeks  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Study participants with
In age group of 20-50 years with uterine fibroid & Volume of Uterine fibroid more than or equal to 2cm3 to 20cm3 found on USG pelvis
HMB PBAC more than 100
Dysmenorrhea VAS more than 5
 
 
ExclusionCriteria 
Details  Study participants with
Pregnancy
Severe symptomatic uterine fibroid PBAC more than 500 and VAS more than 8
Associated Endometriosis Adenomyosis and rapid tumor growth
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in uterine fibroid volume on USG pelvis  baseline and at 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in PBAC and VAS score
Improvement in Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QOL)
 
baseline and at 0,4,8,12 weeks 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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)   06/02/2025 
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="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  

Fibroids also known as fibromyomas, myomas or leiomyomas are the most common benign uterine neoplasms, derived from smooth muscle cells and fibroblasts commonly encountered in reproductive age group women.(1,2)Approximately 30%–35% of women are diagnosed with fibroids on ultrasound, but > 70% of the women develop fibroid by the age of 50 years.(2,3)High prevalence of uterine fibroids (UFs) has led to the profound economical burden on the healthcare system and it contributes to at least one-third and up to half of all hysterectomies.(4,5) Prevalence of UFs from the year 2014 to 2016 was 37.65% in rural south India (Tamil Nadu).(6)Most UFs are usually asymptomatic, while symptomatic patients present with menstrual irregularity (menorrhagia followed by metrorrhagia or polymenorrhagia), abdominal pain, abdominal mass, urinary frequency, urgency and infertility. Symptoms usually depend on the number, size, and site of UFs.(3,5) The size of fibroid may range from tiny seedlings to as large as a melon.(6) UFs are associated with impaired fertility and adverse obstetric outcomes.(1)Treatment options for UFs in conventional medicine include analgesics, iron supplements, vitamin D3, COCs, SPRMs, gonadotropin-releasing hormone (GnRH) agonists and antagonist, drugs modulating the estrogen receptors and surgery (hysterectomy, myomectomy, uterine artery embolization (UAE), and focused ultrasound surgery (FUS), both ultrasound and magnetic resonance guided focused ultrasound surgery).(1,7)These treatment are expensive and are associated with lot of side effects and complications.(7) Moreover, such treatment provides temporary relief from symptoms making the hysterectomy as the definitive treatment and rendering the female infertile.(4,7,8) Thus, an alternate approach with cost effectiveness and fewer side effects is required.

In USM, the description of fibroid is mentioned under the heading of “sal’ah” meaning tumor, which usually consider as Waram Balghami barid.(2,9) Based on the etiology of fibroid, various Unani drugs possessing the properties of anti inflammatory, anti-tumor, antioxidant and antiestrogenic effect are available which may be helpful not only to alleviate the symptoms of uterine fibroid but also to reduce its size.  Hence, present study is contemplated to evaluate the efficacy of oral intake of Munjiz Balgham comprising of Aslussoos,badiyan, badranjboya with Gulqand and local application of zimad of Tukhme- Katan, Hulba, Haloon, with Roughane Bedanjeer(10) in reducing the volume of uterine fibroid.

 

 
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