Functional Constipation. Constipation, unspecified
Conditions
Interventions
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 Jala
in a glass of water, every fasting morning, and take two Placebo tablets containing starch powder with warm water before bed.
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBarimani Shahdis
Shiraz University of Medical Sciences
Outcome results
None listed