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CTRI Number  CTRI/2024/05/066898 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Effect of Hulba in reducing the size of Uterine Fibroid 
Scientific Title of Study   Effect of Hulba in reducing the size of Uterine Fibroid- A Pilot study 
Trial Acronym  Effect of Hulba in uterine fibroid 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ismath Shameem 
Designation  Professor and HoD, Ilmul Qabalat wa Amraze Niswan 
Affiliation  National Institute of Unani Medicine 
Address  Room no. 29, Department of Ilmul Qabalat wa Amraze Niswan, National Institute of Unani Medicine, kottigepalya, magadi main road,Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9449977008  
Fax    
Email  dr.ismaths@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ismath Shameem 
Designation  Professor and HoD, Ilmul Qabalat wa Amraze Niswan 
Affiliation  National Institute of Unani Medicine 
Address  Room no. 29, Department of Ilmul Qabalat wa Amraze Niswan, National Institute of Unani Medicine, kottigepalya, magadi main road,Bangalore


KARNATAKA
560091
India 
Phone  9449977008  
Fax    
Email  dr.ismaths@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ismath Shameem 
Designation  Professor and HoD, Ilmul Qabalat wa Amraze Niswan 
Affiliation  National Institute of Unani Medicine 
Address  Room no. 29, Department of Ilmul Qabalat wa Amraze Niswan, National Institute of Unani Medicine, kottigepalya, magadi main road,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 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Ismath Shameem  National Institute of Unani Medicine  Room no. 29, out patient department of Amraze Niswan (Gynecological OPD), National Institute of Unani Medicine, Kottigepalya, Magadi main road
Bangalore
KARNATAKA 
9449977008

dr.ismaths@gmail.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: N858||Other specified noninflammatory disorders of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Tukhme Hulba (Trigonella foenum-graecum L./fenugreek seeds)  Fenugreek seeds will be taken, finely powdered and stored in an air tight pouch. The patient will be asked to prepare decoction of 7g powder with water (200ml) till the quantity is reduced to half. The decoction so prepared will be sieved and consumed by the patient once daily half an hour before food for 3 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Size of uterine fibroid ranging from 1-6cm documented on USG with or without symptoms 
 
ExclusionCriteria 
Details  Pregnancy, Severe symptomatic uterine fibroid and associated endometriosis or adenomyosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in size of uterine fibroid on USG pelvis  At baseline and after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in symptoms  At baseline, 1 month, 2 months & 3 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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 
Date of First Enrollment (India)   15/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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 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 profound economical burden on healthcare system and it contribute to at least one-third and up to half of all hysterectomies.(4,5) Prevalence of UFs from year 2014 to 2016 was 37.65% in rural south India (Tamil Nadu).(6)Most UFs are usually asymptomatic, while symptomatic patient presents with menstrual irregularity (menorrhagia followed by metrorrhagia or polymenorrhagia), abdominal pain, abdominal mass, urinary frequency, urgency and infertility. Symptoms usually depend on number, size and site of UFs.(3,5) The size of fibroid may range from size of a 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 provide 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 less 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.(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, a pilot study is contemplated to evaluate the efficacy of Tukhme Hulba (Trigonella foenum-graecum L./fenugreek seeds) in reducing the size of uterine fibroid.

 
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