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Clinical Trial Details (PDF Generation Date :- Wed, 11 Jul 2018 10:21:23 GMT) CTRI Number
CTRI/2013/11/004144 [Registered on: 14/11/2013] - Trial Registered Prospectively
Last Modified On
13/06/2014
Post Graduate Thesis No Type of Trial
Interventional
Type of Study
Homeopathy
Study Design
Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study
Homoeopathic intervention in benign breastlumps
Scientific Title of Study
A Multi-centre single blind randomized placebo controlled trial to evaluate the efficacy of individualized Homoeopathic intervention in breast fibroadenoma
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Name Trial Coordinator Designation (multi-center study) Affiliation
Details of Principal Investigator Dr R K Manchanda Director General Central Council of Research in Homoeopathy
Address
Central Council of Research in Homoeopathy, 61-65, Institutional area, Janakpuri, New Delhi West DELHI 110058 India
Phone
011-28525523
Fax Email Details Contact Person (Scientific Query)
[email protected] Details Contact Person (Scientific Query)
Name
Dr Praveen Oberai
Designation
Scientist 4
Affiliation
Central Council of Research in Homoeopathy
Address
Central Council of Research in Homoeopathy, 61-65, Institutional area, Janakpuri, New Delhi West DELHI 110058 India
Phone
011-28525749
Fax Email Details Contact Person (Public Query)
[email protected] Details Contact Person (Public Query)
Name
Dr Chetna Deep Lamba
Designation
Scientist 1
Affiliation
Central Council of Research in Homoeopathy
Address
Central Council of Research in Homoeopathy, 61-65, Institutional area, Janakpuri, New Delhi West DELHI 110058 India
Phone
011-28525749
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Fax Email Source of Monetary or Material Support
[email protected] Source of Monetary or Material Support
> Central Council for Research in Homoeopathy
Primary Sponsor
Primary Sponsor Details Name
Central Council of Research in Homoeopathy
Address
Central Council of Research in Homoeopathy, 61-65, Institutional area, Janakpuri, New Delhi
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
List of Countries
Sites of Study
Name of Principal Investigator
Name of Site
Site Address
Dr Bharti Wadhwa
Central Research Institute (H), Noida
Central Research 01204278431 Institute (H), A – 1/1, Sector 24, Opposite
[email protected] E.S.I. Hospital, Noida, om U.P. - 201301 Gautam Buddha Nagar UTTAR PRADESH
Dr Suraiya Parveen
Dr. Anjali Chatterjee Regional Research Institute (H)
DACRRI (H) 50, 09231758284 Rajendra Chatterjee Road Kolkata – 700035
[email protected] Kolkata WEST BENGAL
Dr Gautam Rakshit
Regional Research Institute (H)
Regional Research 09437281072 Institute (H), Marchikote Lane, Puri – 752001
[email protected] Odisha m Puri ORISSA
Dr Vaishali Shinde
Regional Research Institute, Mumbai
Regional Research 09920425854 Institute (H), MTNL Hall No. 4, Shopping
[email protected] Centre, Sector 9, CBD, Balapur, Navi Mumbai, Maharashtra - 400056 Mumbai MAHARASHTRA
Name of Committee
Approval Status
Date of Approval
Is Independent Ethics Committee?
Ethical Committee of CCRH
Approved
13/03/2013
Yes
Details of Ethics Committee
India Phone/Fax/Email
Regulatory Clearance Status from DCGI
Status
Date
Not Applicable
No Date Specified
Health Condition / Problems Studied
Health Type
Condition
Patients
Breast fibroadenoma
Intervention / Comparator Agent
Type
Name
Details
Intervention
Individualised homoeopathic medicine.
Medicine shall be given in 6c, 30c, 200c or 1M potency to be
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taken orally as per the prescribing totality of the case.Duration of intervention will be 6 months. Patient will be followed up at monthly interval and subsequent treatment shall be given as per the principles of homoeopathy. Comparator Agent
Placebo
Inclusion Criteria
Identical placebo (globules impregnated with non-succussed dispensing alcohol) shall be given to be taken orally to the patients in placebo group for 6 months. The patients will be followed at monthly interval and continued on placebo.
Inclusion Criteria Age From
18.00 Year(s)
Age To
35.00 Year(s)
Gender
Female
Details
i. Female aged 18 to 35 years ii. Diagnosis of breast fibroadenoma based on: Clinical examination, Ultrasound image and confirmation by FNAC iii. Fibroadenoma size between 1 cm and 5 cm at its largest dimension (measured by sonomammography) iv. The tumors may be single, multiple and/or bilateral v. Only one fibroadenoma per quadrant vi. Written Informed consent from the patient
Exclusion Criteria
Exclusion Criteria Details
i. Patient pregnant or lactating ii. Complex fibroadenomas and giant (juvenile) fibroadenoma of the breast iii. Tumors that have hypercellularity suggestive of phylloides, atypia, or equivocal pathology report (e.g. discordance between sonomamography and microscopic results). iv. Fibrocystic disease of the breast v. Tubular adenoma of the breast vi. Hamartoma of the breast vii. Family history of breast cancer or history of laser or radiation therapy to the target breast viii. Cases with other systemic diseases like cardiovascular, endocrinal diseases or Systemic illnesses or on other treatment therapies
Method of Generating Stratified randomization Random Sequence Method of Concealment
Not Applicable
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome Reduction/ resolution of breast fibroadenoma through sonomammography
Timepoints Baseline, 3rd month and 6th month
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Secondary Outcome
Outcome None
Target Sample Size
Total Sample Size=200 Sample Size from India=200
Phase of Trial
Phase 2
Date of First Enrollment (India)
14/02/2014
Date of First Enrollment (Global)
No Date Specified
Timepoints None
Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details
The paper shall be published after completion of the study.
Brief Summary
Fibroadenoma is the most common benign tumor of the breast and the most common breast tumor in women under age 30. Surgical as well as conservative treatment has been described for fibroadenomas. As per the treatment protocol in Modern medicine, patients with fibroadenoma under 35years are to be followed up for 6 months without any intervention. In case, the fibroadenoma doesn’t regress or increases in size, the intervention is required. Although, the preferred management of multiple fibroadenomas is complete excision. However, this approach can lead to undesirable scarring or to extensive ductal damage if all the fibroadenomas are excised through one incision. Conservative treatment also has its limitations. Homoeopathic clinical trials by Moili et al and Gupta et al have shown positive results in cases of Fibroadenoma of breast but short duration of follow up, inadequate sample size and lack of gold standard for diagnosis were the major drawback. Therefore, the Council proposes to conduct a placebo controlled randomized clinical trial to evaluate the efficacy of homoeopathic medicines in the management of Fibroadenoma of breast with the following objectives-. Primary Objective: - To evaluate the efficacy of homoeopathic medicines in reduction of size or resolution of breast fibroadenoma through sonomamograhic assessment Secondary Objective:
- To compare the efficacy of homoeopathic intervention in single and multiple fibroadenomas
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