| CTRI Number |
CTRI/2014/09/005018 [Registered on: 15/09/2014] Trial Registered Prospectively |
| Last Modified On: |
17/10/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Uterine Fibroids-Effect of Ayurvedic regimen |
|
Scientific Title of Study
|
Clinical Evaluation of Khadirarishta and Kanchanara guggulu in the management of Uterine Fibroids-An Exploratory study |
| Trial Acronym |
IMR-UF-TVM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Indirakumari |
| Designation |
Research officer (AY) (SCT-4) |
| Affiliation |
Ayurveda Research Institute for Mother and Child Health care |
| Address |
Ayurveda Research Institute for Mother and Child Health care Poojapura Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9446795133 |
| Fax |
04712342070 |
| Email |
drindirakumari56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Indirakumari |
| Designation |
Research officer (AY) (SCT-4) |
| Affiliation |
Ayurveda Research Institute for Mother and Child Health care |
| Address |
Ayurveda Research Institute for Mother and Child Health care Poojapura Thiruvananthapuram
Wayanad
KERALA
695012
India |
| Phone |
9446795133 |
| Fax |
04712342070 |
| Email |
drindirakumari56@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Indirakumari |
| Designation |
Research officer (AY) (SCT-4) |
| Affiliation |
Ayurveda Research Institute for Mother and Child Health care |
| Address |
Ayurveda Research Institute for Mother and Child Health care Poojapura Thiruvananthapuram
Wayanad
KERALA
695012
India |
| Phone |
9446795133 |
| Fax |
04712342070 |
| Email |
drindirakumari56@gmail.com |
|
|
Source of Monetary or Material Support
|
| Supports in terms of infrastructure facilities:
Ayurveda Research Institute for Mother and Child Health care, Poojapura, Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri
West DELHI 110058
India |
| Type of Sponsor |
Government funding agency |
|
|
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 S Indirakumari |
ARIMCHC-Thiruvananthapuram |
ARIMCHC
Poojapura(PO)-695012
Thiruvananthapuram
KERALA |
9446795133
04712342070
arimchc.trivendrum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe for Biomedical Research of Ayurveda Research Institute for Mother & Child Health Care (CCRAS) Poojapura Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Uterine Fibroids
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Khadirarishta
Kanchanara Guggulu |
Khadirarishta-30 mL twice a day after meals orally (9 Am and 9 PM ) for six consecutive months.
Kanchanara Guggulu-1 gm twice a day with arishta after meals orally (9 Am and 9 PM )for six consecutive months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Symptomatic Females, 25-50 yrs
Uterine fibroids, uterine size< 12 weeks, and at least one fibroid>2 cm but none>5 cm on U/S
Pre menopausal ladies with Uterine Fibroids getting at least 1 menstrual period in last three months.
Normal PAP smear.
|
|
| ExclusionCriteria |
| Details |
Pregnancy, Lactation.
Unexplained vaginal bleeding, cervical dysplasia, abnormal ovarian or adnexal mass.
History of malignancy within the past 5 years.
Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations.
Use of herbal medication having estrogenic or antiestrogenic effect within the past 3 months.
Known recent rapid growth of fibroids, defined as a doubling in size in six months.
Haemoglobin level below 8gm%
Patients suffering from any other major systemic illness necessitating long term drug Therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the clinical symptoms |
At base line 30th day, 60th day, 90th day, 120th day, 150th day and 180th day i.e at the time of trial completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the size of fibroids |
At the screening day, 90th day and end of the study (180th day) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/01/2015 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
To be published after the completion of the trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The proposed study intended to prove and establish the efficacy of khadirarishta and kanchanara guggulu in the management of uterine fibroids with evidence based data scientifically. This study will be conducted in Ayurveda Research Institute for Mother and Child Health Care- a peripheral research institute of CCRAS. Patients are to be identified, screened and selected from ARIMCHC OPD as per criteria. The expected outcome measures are
1. Changes in clinical symptoms
2. Changes in the size of fibroids.
Total trial period of this study is 3 years and treatment duration is 6 months. |