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| ID | Type | Description | Link |
|---|---|---|---|
| 81072920 | Other Grant/Funding Number | National Natural Science Foundation of China |
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The objective of this study is to screen the effective core formulation in insomnia treatment with Chinese medicine with a double-blind, randomized, placebo-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Medicine group | Experimental | Chinese Medicine prescription of one of three prestigious Chinese medicine clinicians |
|
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese herbal Medicine | Drug | The intervention of Chinese Medicine group is not fixed. The clinicians provide the prescription to patient base their own Chinese Medicine theory. Chinese clinicians can adjust the medicinal in prescription based on the condition of patient during the treatment procedure. The prescription of Chinese clinicians' are pure Chinese herb. |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in Total Sleep Time (TST) at 4 weeks | baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in sleep onset latency at 4 weeks | baseline and 4 weeks | |
| change from baseline in wake time after sleep onset at 4 weeks | baseline and 4 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Li, Bachelor | Contact | +8613810991638 | leepanns@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liyun He, Doctor | China Academy of Chinese Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | 100700 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38753273 | Derived | Xiong ZY, Lu Y, He LY, Zhang RS, Zhou XZ, Li P, Liu YJ, Zhu JG, Yan SY, Liu BY. Efficacy of Chinese Medicine Treatment Based on Syndrome Differentiation for Primary Insomnia: A Randomized Placebo Controlled Triple-Blinded Trial. Chin J Integr Med. 2024 Oct;30(10):867-876. doi: 10.1007/s11655-024-3661-4. Epub 2024 May 16. | |
| 23448313 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 31, 2017 | |
| Unrelease | Yes | |
| Release | May 7, 2018 | |
| Reset | Dec 6, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 31, 2017 | Yes | |||
| May 7, 2018 |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| the dummy of a Chinese Medicine prescription | Other | Patients in placebo group will receive the dummy of the core drug patterns screened in previous retrospective study. The previous core drug patterns include Fried semen Ziziphi Spinosae, Tuckahoe, Preparation of Polygala, Chinese Angelica root, Lotus heart, White peony root, dried tangerine peel, acorus calamus, Coptis chinensis, and Licorice health. |
|
| change from baseline in sleep efficiency at 4 weeks |
| baseline and 4 weeks |
| change from baseline in Pittsburgh sleep quality index (PSQI) at 4 weeks | baseline and 4 weeks |
| change from baseline in Chinese Medicine symptoms and signs at 4 weeks | baseline and 4 weeks |
| Yan S, Zhang R, Zhou X, Li P, He L, Liu B. Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial. Trials. 2013 Feb 28;14:61. doi: 10.1186/1745-6215-14-61. |
| Dec 6, 2018 |
| D001523 |
| Mental Disorders |