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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2015/07/005958 |
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Date of registration:
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02-07-2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Homeopathy in treatment of hemorrhoids
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Scientific title:
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Treatment of hemorrhoids with individualized homeopathy: an open observational pilot study |
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Date of first enrolment:
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21-07-2014 |
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Target sample size:
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50 |
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Recruitment status: |
Closed to Recruitment of Participants |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11818 |
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Study type:
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Interventional |
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Study design:
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Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Subhranil Saha
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Address:
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50, Rajendra Chatterjee Road, Kolkata
700035
Rangareddi, WEST BENGAL
India |
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Telephone:
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Email:
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drsubhranilsaha@hotmail.com |
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Affiliation:
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Dr. Anjali Chatterjee Regional Research Institute, under Central Council for Research in Homeopathy |
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Name:
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Subhranil Saha
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Address:
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50, Rajendra Chatterjee Road, Kolkata
700035
Kolkata, WEST BENGAL
India |
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Telephone:
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Email:
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drsubhranilsaha@hotmail.com |
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Affiliation:
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Dr. Anjali Chatterjee Regional Research Institute, under Central Council for Research in Homeopathy |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age 18-65 years, both sexes, suffering from internal idiopathic/primary hemorrhoids grades I-III and presenting with any of the symptoms, namely, bleeding, pain (including discomfort and tenesmus during defecation or any other time), heaviness, pruritus, and mucus discharge with or without anitis. Patients with controlled diabetes and controlled hypertension and thyroid disorders are also eligible for the study. Patients using topical agents for hemorrhoids will be included after a washout period of one week, subject to persistence of symptoms and signs of hemorrhoids.
Exclusion criteria: Grade IV piles, anal fissure and fistula, hereditary piles, inflammatory bowel disease, enlarged prostate, chronic alcoholism, recreational drug abuse, coagulation disorders, external haemorrhoids, previous history of surgery for haemorrhoids, hypertrophic anal papillae, rectal malignancies, history of leukemic disorders, patients with obstruction of portal circulation, pregnancy leading to obstruction of the portal circulation, lactating mothers, patients with psychiatric diseases
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Hemorrhoids (Piles)
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Intervention(s)
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Intervention1: Individualized homeopathic medicine in centesimal or 50 millesimal potencies: In centesimal potencies, each dose shall consist of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 88% v/v ethanol. In 50 millesimal potencies, a single medicated cane sugar globules of poppy seed size (no.10) dissolved in 50 ml distilled water with addition of 2 drops of 88% v/v ethanol, 10 doses marked on the vial, each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid in the cup. Repetition 24, 12 or 8 hourly or even oftener, depending upon the individual requirement of the case.
Control Intervention1: None: Not applicable
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Primary Outcome(s)
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100 mm visual analogue scales measuring changes in intensity of symptoms of hemorrhoids รข?? bleeding, pain, heaviness, discharge, and itchingTimepoint: At baseline, every month, up to 6 months
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Secondary Outcome(s)
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NoneTimepoint: Not applicable
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Secondary ID(s)
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U1111-1169-7497
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MHMCH/19/2015-16 and MBHMCH/70 version 1.0 date 28.05.2014
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Source(s) of Monetary Support
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(1) MB Homeopathic Medical College and Hospital, Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal;
(2) Midnapore Homeopathic Medical College and Hospital, PO and Dist Midnapore, Pin 721101, West Bengal
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Ethics review
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Status: Approved
Approval date: 29/05/2014
Contact:
Institutional Ethics Committee of Mahesh Bhattacharyya Homeopathic Medical College and Hospital
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Status: Approved
Approval date: 22/04/2015
Contact:
Institutional Ethics Committee of Midnapore Homeopathic Medical College and Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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