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IRCT20110907007511N5 IRCT 2021-08-03 Niak Pharmaceutical Company Anti-flatulence effects of ZAX capsule in treatment of bloating GBS Evaluation of anti-flatulence effects of ZAX capsule in comparison with dimethicone in patients with bloating: A crossover clinical trial 2021-06-22 anticipated 50 Complete https://irct.ir/trial/53688 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: The random assignment list will be computer generated with a 1: 1 allocation, stratified by recruitment site, using random block sizes of four. Using concealed in sequentially numbered, sealed, opaque envelopes (SNOSE), participants will enter the blocks in such a way that an equal number of each assigned group. Allocation will be done by randomly selecting one of the arrangements and assigning the next part of the participants to the study groups according to the specified sequence. And kept by the hospital pharmacist of the center, Blinding description: To maintain blindness in patients, since the two drugs ZAX and Dimethicone are not identical in appearance, a placebo of both drugs is made, which is considered as the drug in terms of shape and appearance; In this way, one group will receive ZAX capsules and placebo of Dimethicone tablets and the other group will receive Dimethicone tablets along with placebo of ZAX capsules. In fact, each treatment group contains a drug package containing 2 drug forms (capsules and tablets). Also, the evaluator is not aware of the type of drugs in the intervention groups, so that multi-digit numeric codes (barcodes) are written on the drug packages that only the main person in charge of the research knows about them and can access the codes if needed. And the type of drug is determined. 3 Functional bloating. Intervention 1: Group 1 will receive Dimethicone chewable tablets 40 mg and placebo of Zax capsules 400 mg after each meal for 2 weeks. They will not receive any medication for a week during the washout period. They will then be crossed, receiving for another 2 weeks Zax capsule 400 mg and placebo of Dimethicone 40 mg after each meal. Dimethicone is provided by Sobhan Daroo Company. Intervention 2: Group 2 will receive Zax capsule 400 mg and placebo of Dimethicone 40 mg after each meal. They will not receive any medication for a week during the washout period. They will then be crossed, receiving for another 2 weeks, Dimethicone chewable tablets 40 mg and placebo of Zax capsule 400 mg after each mea. Zax capsules are manufactured by NIAK Company. After collection, the plants are divided into smaller pieces and after drying separately in the shade, they are pulverized by an electric mill. The plants were mixed with the specified ratios (Dry extract of apricots: 25%, dry extract of thyme: 25%, frankincense: 25%, dry extract of black seed: 17.5%, magnesium stearate 0.25%, aerosil 0.75%, starch 6.5%) and finally a capsule with a filled weight of 400 mg was prepared in the filling section without pus. The standardization of the capsule with 3.67 mg of thymol in each capsule was done by spectrophotometric method according to the German Pharmacopoeia. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Dr. Marzieh Qaraati
Shastkola Road
Gorgan Iran (Islamic Republic of) 14395-477 +98 17 3245 1434 Dr.qaraati@goums.ac.ir Gorgan University of Medical Sciences scientific Dr. Marzieh Qaraati
Shastkola Road
Gorgan Iran (Islamic Republic of) 14395-477 +98 17 3245 1434 Dr.qaraati@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Conscious consent to participate in the study Symptoms of bloating include a feeling of bloating or visible abdominal distention in at least the last three months and with the onset of symptoms at least six months ago Frequent bloating at least one day a week (moderate to severe bloating intensity) Normal abdominal examinations Normal colonoscopy in people over 50 years of age in the last year before entering the study No irritable bowel syndrome, functional constipation, functional indigestion or other gastrointestinal dysfunction Normality of tests: CBC, ESR TSH, Ca, P and Stool exam for leukocyte, OB, OP (parasite in feces, occult blood and leukocytes) and AST, ALT, ALP, BUN, Cr, FBS TTGA (IgA) (for celiac disease). ) 18 years 65 years Both Pregnant or lactating women Sensitivity to one of the herbs that make up the product History of chronic inflammation or structural disorders of the gastrointestinal system such as IBD, known peptic or duodenal ulcer, gastrointestinal obstruction or symptomatic gallstones Chronic diseases such as diabetes, thyroid dysfunction and uncontrollable hypertension Serious systemic disease (heart, kidney, lung and liver failure) Lactose intolerance (lactase deficiency) Dangerous symptoms such as involuntary weight loss of more than 4 kg in the last three months and blood in the stool or melena or bloody vomiting in the last three months History of gastrointestinal surgery other than appendectomy, inguinal hernia or abdominal wall, cesarean section, hysterectomy and tubal ligation Cancer Use of drugs affecting gastrointestinal motility (such as surfactants, antispasmodics), laxatives and any herbal anti-flatulence medication in the two weeks before the study Take antibiotics one month before the start of the study Substance or alcohol abuse R14.0 Abdominal distension Treatment - Drugs Treatment - Drugs Group 1 will receive Dimethicone chewable tablets 40 mg and placebo of Zax capsules 400 mg after each meal for 2 weeks. They will not receive any medication for a week during the washout period. They will then be crossed, receiving for another 2 weeks Zax capsule 400 mg and placebo of Dimethicone 40 mg after each meal. Dimethicone is provided by Sobhan Daroo Company. Group 2 will receive Zax capsule 400 mg and placebo of Dimethicone 40 mg after each meal. They will not receive any medication for a week during the washout period. They will then be crossed, receiving for another 2 weeks, Dimethicone chewable tablets 40 mg and placebo of Zax capsule 400 mg after each mea. Zax capsules are manufactured by NIAK Company. After collection, the plants are divided into smaller pieces and after drying separately in the shade, they are pulverized by an electric mill. The plants were mixed with the specified ratios (Dry extract of apricots: 25%, dry extract of thyme: 25%, frankincense: 25%, dry extract of black seed: 17.5%, magnesium stearate 0.25%, aerosil 0.75%, starch 6.5%) and finally a capsule with a filled weight of 400 mg was prepared in the filling section without pus. The standardization of the capsule with 3.67 mg of thymol in each capsule was done by spectrophotometric method according to the German Pharmacopoeia. The severity of bloating. Timepoint: 1. Time 0: The beginning of the study (face-to-face visit)2. Time 1: Two weeks after receiving the drug of stage 1 (face-to-face visit)3. Time 2: End of stage 1 drug course and one week washout, cross-sectional study and start of stage 2 drug treatment and reuse of drugs (face-to-face visit)4. Time 3: 2 weeks after receiving stage 2 medication (face-to-face visit)5. Time 4: First follow-up - 2 weeks after the end of the drug (telephone follow-up)6. Time 5: Second follow-up - 4 weeks after the end of the drug (telephone follow-up)7. Time 6: Third follow-up - 8 weeks after the end of the drug (face-to-face visit). Method of measurement: face-to-face visits and telephone follow-up. The frequency of bloating. Timepoint: 1. Time 0: The beginning of the study (face-to-face visit)2. Time 1: Two weeks after receiving the drug of stage 1 (face-to-face visit)3. Time 2: End of stage 1 drug course and one week washout, cross-sectional study and start of stage 2 drug treatment and reuse of drugs (face-to-face visit)4. Time 3: 2 weeks after receiving stage 2 medication (face-to-face visit)5. Time 4: First follow-up - 2 weeks after the end of the drug (telephone follow-up)6. Time 5: Second follow-up - 4 weeks after the end of the drug (telephone follow-up)7. Time 6: Third follow-up - 8 weeks after the end of the drug (face-to-face visit). Method of measurement: the frequency of bloating. Satisfaction of treatment. Timepoint: the end of the study. Method of measurement: questionnaire. Niak Pharmaceutical Company Approved 2021-05-31 Golestan University of Medical Sciences Shast-Kolah Road Gorgan Golestan Iran (Islamic Republic of)