Multicenter, randomized positive control, efficacy evaluation protocol for the treatment of functional constipation with shouhui tongbian capsules

Authors
Category Primary study
Registry of TrialsITMCTR
Year 2022
INTERVENTION: Control group:Oral solution of lactulose, initial dose of 30 ml daily total dose, 1 sachet of 15 ml once, 2 times a day, maintenance dose of total daily dose of 15 ml, 1 bag at a time, once a day, oral, continuous medication for 2 weeks, after 1 week of discontinuation, continue to use the drugExperimental group:First Laxative Capsules, 0.35g per capsule, oral, 2 capsules at a time, 3 times daily for 2 weeks, after 1 week of discontinuation, continue for 2 weeks; the course of treatment is 4 weeks ; CONDITION: Functional constipation PRIMARY OUTCOME: Total effective rate of treatment: total effective rate = (effective + effective) number of cases / total number of cases ×1 00%; SECONDARY OUTCOME: Bowel onset time;Evaluation of stool traits;The number of completely spontaneous bowel movements (CSBM) per week;Quality of life evaluation;TCM evidence of therapeutic effect;Frequency of bowel movements;Frequency of spontaneous bowel movements in the 12th week after the first dose; INCLUSION CRITERIA: (1) Meet the Roman IV diagnostic criteria for functional constipation; (2) Meet the diagnostic criteria of Constipation Qi Yin and Yin In Traditional Chinese Medicine; (3) Age 40‐75 years old, male or female; (4) Voluntarily participate in this study and sign an informed consent form.
Epistemonikos ID: 51ca68557047cab37b4550099fa4af9596ccbb3f
First added on: Aug 26, 2024