| 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
|
|
|
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
|
|
|
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. |