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IRCT20170929036482N2 IRCT 2018-10-24 Traditional Medicine school of Tehran University The effectiveness of a topical form of Cassia fistula L. on Constipation The effectiveness of a topical preparation of Cassia fistula L. on navel for the treatment of functional constipation 2016-04-02 anticipated 150 Complete https://irct.ir/trial/27258 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: no, Randomization description: Patients were randomly divided into two groups by Permuted Block randomization. The number of blocks was 2, 4, and 6. Then, with the random numbers generated by the computer, the arrangement of the blocks was determined, and the blocks were sorted in the order in which the two drugs were placed. Based on the arrangement, the two groups of drugs were each written in one sheet and placed in the same envelope with a three-digit code on it. After identifying the conditions of entry into the study, the physician referred the patient to the person who provided the envelopes, and the person submitted the envelope to the patient without knowing the contents of the envelope by inserting a three digit number on the patient's envelope. Then he opened the envelope pharmacy technician and, according to the inscription in the envelope marked A and B, provided the patient with the drugs named by the same name and no other information on the drug label. In this study, the doctor was unaware of the patient's position in the drug groups, the secretary and the pharmacist and the patient himself were unaware. At the end of the study, the three-digit code, patient group and results of the three stages (before the study, the second week, the fourth week) were delivered to the statistical adviser and the results were obtained, Blinding description: Drug and placebo are delivered in 2 separate packages A and B, to the person in charge of delivery of the medication, and they do not have any information on the content. The physician and researcher who is the same person does not know what medicine they received. Statistics analyze and compare the two groups on the basis of the data without knowing the drug type of each group. Just the fourth person who has delivered the medication to the person in charge of delivery of the medication knows drug and placebo group. 3 Functional Constipation. Intervention 1: Patients were divided into two groups A and B. During the first two weeks, group A received Cassia fistula or placebo. Subsequently in one weeks, they did not receive any medication (washout time) up to a week. Then, for 2 weeks, group A received another drug (cassia fistula or placebo). The patients apply the drug and placebo to the navel, six times at day and each time six gram. Intervention 2: Patients were divided into two groups A and B. During the first two weeks, group A received Cassia fistula or placebo. Subsequently in one weeks, they did not receive any medication (washout time) up to a week. Then, for 2 weeks, group A received another drug (cassia fistula or placebo). The patients apply the drug and placebo to the navel, six times at day and each time six gram. Yes - There is a plan to make this available What will be shared: Demographic information and biographies and examinations to enter the study - Questionnaires at 3 times mentioned - Statistical methods When: Since the beginning of 2018 March To whom: All Researchers in all disciplines Conditions: There is no condition Where to obtain: Email: herbal_med777@yahoo.com How to obtain: Documents will be submitted to the applicant for a maximum of 1 month. Comments:
public Mohsen Keshavarz
Ahmadiye Clinic, Traditional Medicine school, Felestin Square
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 3656 herbal_med777@yahoo.com Tehran University scientific Mohsen Keshavarz
Traditional Medicine school of Tehran University
Tehran Iran (Islamic Republic of) 1668753961 +98 21 8899 3656 herbal_med777@yahoo.com Traditional Medicine school of Tehran University Iran (Islamic Republic of) Age between 18 to 50 years Confirmation of functional constipation diagnosis based on Rome III criteria 18 years 50 years Both Pregnancy, , , , , , , , Lactating women History of abdominal surgery Gastrointestinal bleeding Psychosis Recent surgery Serious Heart or Liver diseases or Endocrine disorders (Diabetes, Thyroid dysfunction) Cancer Anemia K59.0 Constipation Treatment - Drugs Treatment - Drugs Patients were divided into two groups A and B. During the first two weeks, group A received Cassia fistula or placebo. Subsequently in one weeks, they did not receive any medication (washout time) up to a week. Then, for 2 weeks, group A received another drug (cassia fistula or placebo). The patients apply the drug and placebo to the navel, six times at day and each time six gram. Patients were divided into two groups A and B. During the first two weeks, group A received Cassia fistula or placebo. Subsequently in one weeks, they did not receive any medication (washout time) up to a week. Then, for 2 weeks, group A received another drug (cassia fistula or placebo). The patients apply the drug and placebo to the navel, six times at day and each time six gram. Frequency of defecation per week. Timepoint: Before the study, end of week 2, end of week 4. Method of measurement: A questionnaire based on Rome III criteria. Frequency of hard stool. Timepoint: Before the study, end of week 2, end of week 4. Method of measurement: A questionnaire based on Rome III criteria. Frequency of straining during defecation. Timepoint: Before the study, end of week 2, end of week 4. Method of measurement: A questionnaire based on Rome III criteria. Frequency of sensation of incomplate evacuation. Timepoint: Before the study, end of week 2, end of week 4. Method of measurement: A questionnaire based on Rome III criteria. Frequency of sensation of anorectal blockage. Timepoint: Before the study, end of week 2, end of week 4. Method of measurement: A questionnaire based on Rome III criteria. Frequency of manual maneuvers to facilitate defecation. Timepoint: Before the study, end of week 2, end of week 4. Method of measurement: A questionnaire based on Rome III criteria. Skin complication at the site of topical use. Timepoint: Before study, end of week 2, end of week 4. Method of measurement: A questionnaire. Any possible complications. Timepoint: Before study, end of week 2, end of week 4. Method of measurement: A questionnaire. Traditional Medicine school of Tehran University Approved 2016-04-02 Tehran University of Medical Sciences Tehran University of Medical Sciences, Enghelab square Tehran Tehran Iran (Islamic Republic of)