The effectiveness of a topical preparation of Cassia fistula L. on navel for the treatment of functional constipation

The effectiveness of a topical product of Cassia Fistula L. on navel for the treatment of functional constipation.

150 patients aged 18 to 50 years old with eligible functional constipation who were referred to the clinics of the Faculty of Traditional Medicine of Tehran University were divided into two groups, so that the two groups were matched in terms of age and sex, each patient had a code

The study is done at the traditional medicine clinics of Tehran University. A group involve 75 people, recieve drug A and another group recieve drug B for 2 weeks. After a washout period, the groups use another drug (A or B). The questionnaire was filled in the first and at the end of the second week and at the end of the last 2 weeks. The physician, the provider of the drug to the patient and statistics consultant are not informed about the drug or placebo status of the product. The drug and placebo are named in two categories A and B.

Inclusion Criteria: Age between 18 and 50 and confirmation of functional constipation diagnosis based on the Rome III criteria. Exclusion Criteria: Pregnancy, breastfeeding, history of abdonimal or gastrointestinal surgery, gastrointestinal bleeding, psychosis, recent surgery, serious heart or liver or endocrine disease (Diabet mellitus , thyroid dysfunction), cancer and anemia.

Drug group: receive topical production of Cassia Fistula Placebo group: receive topical production of placebo

Determine the effect of topical drug on the navel on: 1. Frequency of bowel movements per week 2. Stool consistency 3. Straining during evacuation 4. Sensation of incomplete defecation 5. Sensation of anorectal blockage 6. Manual maneuver to Facilitate defecation

tehran university

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.

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.

Demographic information and biographies and examinations to enter the study - Questionnaires at 3 times mentioned - Statistical methods

Since the beginning of 2018 March

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