| 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
|
|
|
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
|
|
|
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. |