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IRCT20190312043025N1 IRCT 2020-01-20 Shiraz University of Medical Sciences The Efficacy of Jalinous tablet compared with Placebo on adult functional constipation The Efficacy of Habb-e Jalinous and Psyllium compared with Placebo and Psyllium on adult functional constipation: A double blinded clinical trial 2019-01-22 anticipated 126 Complete https://irct.ir/trial/44130 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients eligible for inclusion criteria, by using balanced the block randomization with Excel computer software, will randomly be divided into two groups: A: Jalinous tablet and Psyllium sachet, B: Placebo tablet and Psyllium sachet, Blinding description: Drugs will be packaged in two groups (A and B) by a person whom won't participate in study. Patients, physicians and all person that participate in collecting data would be blinded. After analysis, the contents of the package will be announced. 3 Functional Constipation. Intervention 1: Intervention group: every morning when fasting, patients using a 10 gram Psyllium granule sachet; manufactured by Dineh company with registration code 6911052432012790 witch made from Plantago Psyllium seed; in a glass of water, and take two Jalinous tablet (Habbe - Rahat), licensed to administer natural, traditional and complementary products No.s-0212-92, containing: mastic, Aloe Vera, Rose, Indian Jalap, with warm water before bed. Intervention 2: Control group: Patients, take a 10 gram Psyllium granule sachet; manufactured by Dineh company with registration code 6911052432012790 witch made from Plantago Psyllium seed; in a glass of water, every fasting morning, and take two Placebo tablets containing starch powder with warm water before bed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more data
public Barimani Shahdis
Shiraz University of Medical Science, Imam Hossein Square, Zand street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3234 5145 sbarimani@sums.ac.ir Shiraz University of Medical Sciences scientific Barimani Shahdis
Shiraz University of Medical Science, Imam Hussein Square, Zand Street
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3234 5145 sbarimani@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 18 to 50 years old Ability to understand, speak and answer the questions Qualified for ROME IV functional constipation Confirmed functional constipation diagnosis by gastrointestinal specialist Non-pregnancy and lactation Complete the consent form 18 years 50 years Both New disease that may lead to hospitalization or new medications Use other laxatives when studying more than 2 times a week Drug Addiction Alarm signs (rectal bleeding, fever, loss of appetite, weight loss, ...) Incidence of severe side effect of the study drug The patient's unwillingness to continue participating in the study for any reason No regular drug use (more than 7 days) Have a history of allergy to aloe Vera, rose, Indian Jalap and mastic Recent use of antacid, anticholinergic, anti Parkinson, anti psychotic and tricyclic antidepressants, anticonvulsants, antidepressants, diuretics and calcium blockers, iron products, opioids, calcium, prophylaxis Contains progesterone Previous history of any abdominal and gastrointestinal surgery K59.00 Constipation, unspecified Treatment - Drugs Treatment - Drugs Intervention group: every morning when fasting, patients using a 10 gram Psyllium granule sachet; manufactured by Dineh company with registration code 6911052432012790 witch made from Plantago Psyllium seed; in a glass of water, and take two Jalinous tablet (Habbe - Rahat), licensed to administer natural, traditional and complementary products No.s-0212-92, containing: mastic, Aloe Vera, Rose, Indian Jalap, with warm water before bed. Control group: Patients, take a 10 gram Psyllium granule sachet; manufactured by Dineh company with registration code 6911052432012790 witch made from Plantago Psyllium seed; in a glass of water, every fasting morning, and take two Placebo tablets containing starch powder with warm water before bed. Changes in frequency of defecation. Timepoint: Before intervention and after 14 and 28 days of treatment. Method of measurement: Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner.We will evaluate the frequency of defecation as per week. Changes in incomplete defecation and evacuation. Timepoint: Before intervention and after 14 and 28 days of treatment. Method of measurement: Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner. We will evaluate the percent of incomplete defecation from 0-100 (never to always). Changes in straining. Timepoint: Before intervention and after 14 and 28 days of treatment. Method of measurement: Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner. We will evaluate the percent of straining from 0-100 (never to always). Changes in using of manual maneuver. Timepoint: Before intervention and after 14 and 28 days of study. Method of measurement: Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner. We will evaluate the percent of manual maneuver from 0-100 (never to always). Changes of hard stool. Timepoint: Before intervention and after 14 and 28 days of study. Method of measurement: Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner. We will evaluate the percent of hard stool from 0-100 (never to always). Changes in stool consistency. Timepoint: According to Bristol stool scale, at baseline, week 2 and 4. Method of measurement: The Bristol stool scale will be used to specify the stool forms: types 1 and 2 considered as hard, 3 and 4 as normal and 5 to 7 as loose stool. Overall improvement in each symptoms will be assessed and categorized as complete or partial improvement, same and worse. Overall self-reported improvement in symptoms after treatment. Timepoint: At the end of intervention. Method of measurement: After intervention based on patients attitude, Using the options of: deterioration, unchanged, partial recovery and complete recovery. Side effects. Timepoint: At the end of week 2 and 4. Method of measurement: Using the check lists. Shiraz University of Medical Sciences Approved 2019-01-21 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Science, Imam Hussein Square, Zand street Shiraz Fars Iran (Islamic Republic of)