REF/2014/03/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Wed, 28 Feb :13:58 GMT) CTRI Number Last Modified On 13/02/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/06/ [Registered on: 03/06/2015] - Trial Registered Retrospectively No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A CLINICAL TRIAL COMPARING 2 NUTRITIVE SUPPLEMENTS IN THE TREATMENT OF MASTALGIA (PAIN IN THE BREAST) A RANDOMISED PLACEBO CONTROLLED TRIAL COMPARING 2 NUTRITIVE SUPPLEMENTS IN THE TREATMENT OF MASTALGIA Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Designation Affiliation Details of Principal Investigator Dr Ankita Harijee Phone Fax Designation Affiliation Post graduate in General Surgery Kasturba Medical College, Manipal Department of General Surgery, Surgery OPD 11 A, Kasturba Medical College, Manipal ankita_harijee@yahoo.com Details Contact Person (Scientific Query) Dr Stanley Mathew Professor of General Surgery Kasturba Medical College, Manipal Breast Clinic, Department of General Surgery, Surgery OPD 12 B, Kasturba Medical College, Manipal Phone Fax Designation Affiliation stan_mathew@rediffmail.com Details Contact Person (Public Query) Dr Badareesh L Assistant Professor in General Surgery Kasturba Medical College, Manipal, Department of General Surgery, Surgery OPD 11 A, Kasturba Medical College, Manipal page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Phone Fax drbadareesh.l@gmail.com Source of Monetary or Material Support > 1) Torrent Pharmaceuticals Limited 2) Meyer Organics Pvt Limited 3)Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Type of Sponsor List of Countries of Principal Investigator Ankita Harijee Primary Sponsor Details TORRENT PHARMACEUTICALS LIMITED AND MEYER ORGANICS PRIVATE LIMITED 1) Torrent Pharmaceuticals Limited, Off. Ashram Road, Ahmedabad Gujarat, 2)Meyer Organics Private Limited, A-303, Road No. 32, Wagle Estate, Thane (Mumbai), Maharashtra,. Pharmaceutical industry-n of Site Site Phone/Fax/ Breast Clinic, Kasturba Hospital, Manipal Breast Clinic, Outpatient Department of General Surgery, Surgery OPD 12 B, Kasturba Hospital, Manipal ankita_harijee@yahoo. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Approved 08/10/2013 Yes Committee,Kasturba Ho spital,manipal Status Not Applicable Health Type Patients Date No Date Specified Condition Patients with mastalgia Type Details Intervention EDGE-P PLUS Capsule mg once daily for 90 days Each soft gelatin capsule contains- 1)Evening Primrose Oil-1000 mg 2)Mehylcobalamin-750 mcg 3)Excipients-Mixed Tocopherol Comparator Agent PLACEBO One capsule daily for 90 days Intervention WELLWOMAN Capsule mg -Once daily for 90 days Each soft gelatin capsule contains- 1)Starflower oil -100 mg 2)Evening Primrose Oil- 100 mg 3)Vitamin C -60 mg 4)Nicotinamide -36 mg 5)Vitamin E-30 mg 6)Para Aminobenzoic Acid -30 mg 7)Elemental Magnesium-25 mg page 2 / 7

3 Inclusion Criteria Age From Age To Gender Details Year(s) Year(s) Female Inclusion Criteria 8)Vitamin B6-25 mg 9)Elemental Iron-12 mg 10)Elemental Zinc-12 mg 11)Citrus Bioflavinoids -10 mg 12)Vitamin B1-10 mg 13)Calcium Pantothenate-6 mg 14)Vitamin B2-5 mg 15)Elemental Manganese-2.5 mg 16)Betacarotene-2 mg 17)Elemental Copper-1500 mcg 18)Folic Acid-400 mcg 19)Elemental Selenium-100 mcg 20)Vitamin K-90 mcg 21)Biotin-50 mcg 22)Elemental Chromium-50 mcg 23)Vitamin D3-25 mcg(1000 I.U.) 24)Vitamin B12-20 mcg Energy:4.072kcal Carbohydrates-0.044g Fats-0.338g Proteins-0.137g 1) Female patients above 18 years of age 2) Patients complaining of cyclical or noncyclical mastalgia Exclusion Criteria Details Exclusion Criteria 1)Patients with carcinoma of the breast 2)Patients with history of seizures 3) Patients on anticonvulsants, phenothiazines or lithium 4)Patients with breast abscess, mastitis or nipple discharge 5)Lactating and pregnant patients 6)Patients on estrogen therapy, digoxin, anticoagulants 7)Patients with breast trauma or after breast surgery Method of Generating Random Sequence Method of Concealment Blinding/Masking Other Pre-numbered or coded identical Containers Participant and Investigator Blinded Primary Outcome Outcome Timepoints Reduction in breast pain 3 months and 6 months Secondary Outcome Outcome Timepoints Target Sample Size Not applicable Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Total Sample Size=90 Sample Size from =90 22/08/2014 No Date Specified Years=2 Months=0 Days=0 Not applicable page 3 / 7

4 Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Not Applicable Open to Recruitment Nil The study is a randomized placebo controlled trial comparing the efficacy of EDGE-P PLUS Capsule and WELLWOMAN Capsule with a PLACEBO in reducing mastalgia. Aim : To assess and compare the effectiveness of 2 different drugs in the treatment of mastalgia in comparison to a placebo. Materials and Methods : Patients coming to the Breast Clinic, Outpatient Department of General Surgery, Kasturba Hospital, Manipal with breast pain - from 15 th March 2014 to 15 th March 2016 (2 years). Sample size : 90 patients Study type : Randomised placebo-controlled trial Procedure : During the first visit, patients who complain of mastalgia would be pre evaluated with a detailed clinical history and a physical examination. After initial standard evaluation to rule out pathological conditions including breast cancer, patient is introduced to the clinical trial, by the investigator. Eligibility is asessed based on inclusion and exclusion criteria. If the patient is willing and after obtaining an informed consent, the patient is then asked to maintain details of the mastalgia in a predesignated chart and the severity is assessed by Visual Analog Scale. The patient is then reviewed in the Breast Clinic after a minimum period of one full menstrual cycle. At the review the patient is then randomized into one of the 3 groups 1. Mast - W (Wellwoman) 2. Mast - E (Edge - P Plus) 3. Mast - P (Placebo) The Mast - P group will be prescribed Edge - P Plus (Evening Primrose Oil 1000 mg with Methylcobalamine) capsule once daily, after food for 3 months. The Mast - W group of patients will be prescribed Wellwoman (Evening Primrose Oil 100 mg in combination with Star Flower Oil 100 mg and multiple vitamins) 1 capsule once daily, after food for 3 months. The third group of patients will be prescribed a placebo capsule (prepared by Department of Pharmaceutics, MCOPS, Manipal) once daily, after food for 3 months. Edge -P Plus : Each soft gelatin capsule contains - 1) Evening Primrose Oil-1000 mg 2) Methycobalamin-750 mcg 3) Excipients-Mixed Tocopherol Wellwoman : Each soft gelatin capsule contains- 1) Starflower Oil -100 mg 2) Evening Primrose Oil-100 mg 3) Vitamin C-60 mg 4) Nicotinamide -36 mg page 4 / 7

5 5) Vitamin E-30 mg 6) Para amino benzoic acid-30 mg 7) Elemental Magnesium -25 mg 8) Vitamin B6-25 mg 9) Elemental Iron-12 mg 10) Elemental Zinc-12 mg 11) Citrus Bioflavinoids-10 mg 12) Vitamin B1-10 mg 13) Calcium Pantothenate-6 mg 14) Vitamin B2-5 mg 15) Elemental Manganese-2.5 mg 16) Betacarotene-2 mg 17) Elemental Copper-1500 mcg 18) Folic Acid-400 mcg 19) Elemental Selenium-100 mcg 20) Vitamin K- 90 mcg 21) Biotin-50 mcg 22) Elemental Chromium -50 mcg 23) Vitamin D3-25 mcg(1000 I.U.) 24)Vitamin B12-20 mcg page 5 / 7

6 Data will be collected on a pre-designed proforma. Follow-up will be performed at the end of the third menstrual cycle. At that time, the severity, duration and side effects of intervention shall be evaluated using a breast pain chart provided to the patient (filled every day for 3 months). If there is significant relief of mastalgia, the patient would be continued with the same therapy for 3 more months. If there is no significant relief, the patient is asked to discontinue therapy. The response to treatment shall be assessed by an independent consultant who would be blinded to the intervention. The pain assessment would be by using a visual analogue pain score as well as the Cardiff Breast Score to assess the severity of pain at follow-up for each category - cyclical and non-cyclical mastalgia. page 6 / 7

7 Powered by TCPDF ( REF/2014/03/ The primary outcome assessed is reduction in the breast pain page 7 / 7