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To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chang'an I Recipe | Experimental | Patients in this group were administered the Chang'an I Recipe for 8 weeks. |
|
| Placebo | Placebo Comparator | Patients in this group were administered the placebo for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chang'an I Recipe | Drug | Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) | Score less than 75 points was considered as in remission, 75~175 as mild, 175~300 as moderate, and over 300 as severe. | IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum markers regarding liver and kidney function | at baseline and 8 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| xudong Tang, Ph.D | XiYuan Hospital of China Academy of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital | Beijing | Beijing Municipality | 100091 | China | ||
| Wangjing Hospital |
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| Placebo | Drug | Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks. |
|
|
| Beijing |
| Beijing Municipality |
| 100102 |
| China |
| Dongzhimen Hospital | Beijing | Beijing Municipality | 100700 | China |
| Longhua Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| Zhejiang Provincial Hospital of TCM | Hangzhou | Zhejiang | 310006 | China |