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IRCT20200303046677N1 IRCT 2020-05-05 Shahid Beheshti University of Medical Sciences Effect of Ayarij-e-Faiqra on functional constipation Effect of Ayarij-e-Faiqra on functional constipation in adults referring to Clinic 2014-04-21 anticipated 80 Complete https://irct.ir/trial/47325 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients eligible for randomization to one of two drug or placebo groups, according to a randomization table generated by computer excel software. The prescribing physician, assistant, and patient will not be aware of any capsules content, and the capsules code will be written to the file (double-blind). Randomization Unit: Individual Randomization Tool: randomization table, Blinding description: The capsules code will be written to the file. The Prescribing physician, assistant, and patient will not be aware of any capsules content. (Double-blind). 3 functional constipation. Intervention 1: Intervention group: Ayarij-e-Faiqra. AF was prepared according to the “Qarabadin Kabir” textbook. prepared under the supervision of the professors of pharmacy of the Faculty of Traditional Medicine by identifying single drugs, quality control of medicinal plants, processing, and preparation of formulation and microbial control based on the latest available standards. It was a combination of Cinnamomum zeylanicum bark, Pistacia lentiscus oleo gum resin, Cinnamomum cassia bark, Asarum europaeum rhizome, Commiphora opobalsamum fruit and wood, and Nardostachys jatamansi rhizome, Crocus sativus stigma and Aloe vera juice (1:1:1:1:1:1:1:0.14:7.14). All the components were powdered, sieved and mixed, then packed in 500 mg hard gelatin capsules. The daily dose of the drug was 1-2 capsules, half an hour before bedtime with warm water and the duration of intervention was three months. At first, each patient consumed one capsule every night, and if he/she had not enough bowel movements, the dose increased to two capsules/day. In the situation of intolerant of constipation, the patient could use a laxative, which was a tablet (C-lax) containing senna leaf. Intervention 2: Control group: placebo. The placebo was prepared from corn starch in the same color and size capsules. The daily dose of the placebo was 1-2 capsules, half an hour before bedtime with warm water and the duration of intervention was three months. 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 information
public Rasool Choopani
No.8, Valiasr Ave., Shams Ali
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rchoopani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Rasool Choopani
No.8, Valiasr Ave., Shams Ali
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rchoopani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The ability to participate in the whole study Absence of significant behavioral disorders Speech in understandable language Completion of the consent form and having at least six months of history of constipation according to Rome III criteria. 18 years 50 years Both Sensitivity to herbal medicines Diagnosis of obstructive constipation by a gastroenterologist based on history or colon transit Consumption drugs that cause constipation in the recent month (anticholinergic drugs, tricyclic antidepressants, calcium channel blockers, anti-Parkinson's drugs, sympathomimetics, antipsychotics, diuretics, iron supplements, anti-inflammatory drugs, hormonal drugs) Abuse narcotics, stimulants, cannabis, alcohol and pseudo pirates Illnesses affecting constipation Warning signs (rectal bleeding, weight loss or anemia) Unpredictable complications were leading to intolerance to the drug or placebo such as idiosyncratic disease Secondary constipation to diseases, and medications Gastrointestinal complications that impede the continuation of the study Unwilling to continue the study and lack of cooperation. K59.0 Constipation Treatment - Drugs Placebo Intervention group: Ayarij-e-Faiqra. AF was prepared according to the “Qarabadin Kabir” textbook. prepared under the supervision of the professors of pharmacy of the Faculty of Traditional Medicine by identifying single drugs, quality control of medicinal plants, processing, and preparation of formulation and microbial control based on the latest available standards. It was a combination of Cinnamomum zeylanicum bark, Pistacia lentiscus oleo gum resin, Cinnamomum cassia bark, Asarum europaeum rhizome, Commiphora opobalsamum fruit and wood, and Nardostachys jatamansi rhizome, Crocus sativus stigma and Aloe vera juice (1:1:1:1:1:1:1:0.14:7.14). All the components were powdered, sieved and mixed, then packed in 500 mg hard gelatin capsules. The daily dose of the drug was 1-2 capsules, half an hour before bedtime with warm water and the duration of intervention was three months. At first, each patient consumed one capsule every night, and if he/she had not enough bowel movements, the dose increased to two capsules/day. In the situation of intolerant of constipation, the patient could use a laxative, which was a tablet (C-lax) containing senna leaf. Control group: placebo. The placebo was prepared from corn starch in the same color and size capsules. The daily dose of the placebo was 1-2 capsules, half an hour before bedtime with warm water and the duration of intervention was three months Straining during at least 25% of defecations. Timepoint: The end of 1, 2, 3 months, and three months after the end of the intervention. Method of measurement: A questionnaire filled out by the researcher using the interview method. Lumpy or hard stools in at least 25% of defecations. Timepoint: The end of 1, 2, 3 months, and three months after the end of the intervention. Method of measurement: A questionnaire filled out by the researcher using the interview method. The sensation of incomplete evacuation for at least 25% of defecations. Timepoint: The end of 1, 2, 3 months, and three months after the end of the intervention. Method of measurement: A questionnaire filled out by the researcher using the interview method. Sensation of anorectal obstruction/blockage for at least 25% of defecations. Timepoint: The end of 1, 2, 3 months, and three months after the end of the intervention. Method of measurement: A questionnaire filled out by the researcher using the interview method. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor). Timepoint: The end of 1, 2, 3 months, and three months after the end of the intervention. Method of measurement: A questionnaire filled out by the researcher using the interview method. Fewer than three defecations per week. Timepoint: The end of 1, 2, 3 months, and three months after the end of the intervention. Method of measurement: A questionnaire filled out by the researcher using the interview method. Loose stools are rarely present without the use of laxatives. Timepoint: The end of 1, 2, 3 months, and three months after the end of the intervention. Method of measurement: A questionnaire filled out by the researcher using the interview method. Patient satisfaction. Timepoint: The end of 1, 2, 3 months, and three months after the end of the intervention. Method of measurement: Using the visual analogue scale questionnaire, ten scores were filled in by the researcher using the interview method. Shahid Beheshti University of Medical Sciences Approved 2014-03-11 the Medical Ethics Committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. tehran Tehran Iran (Islamic Republic of)