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Stepwise effectiveness evaluation based on syndrome differentiation

Stepwise effectiveness evaluation based on syndrome differentiation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013116
Enrollment
Unknown
Registered
2017-10-26
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

Group A:Qintan Ningshen decoction
Group B:Xiangfu Wendan decoction
Control group:Huanglian Wendan decoction

Sponsors

China Academy of Chinese Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Signed the informed consent; 2. Aged between 18 and 60 years; 3. Subacute or chronic insomnia with one or more months duration; 4. Primary insomnia except for the familial fatal insomnia; 5. General score of Spiegel questionnaire is bigger than 9; 6. Syndrome differentiation is the disturbed spirit due to phlegm-heat.;Inclusion criteria: 1. Signed the informed consent; 2. Aged between 18 and 60 years; 3. Subacute or chronic insomnia with one or more months duration; 4. Primary insomnia except for the familial fatal insomnia; 5. General score of Spiegel questionnaire is bigger than 9; 6. Syndrome differentiation is the disturbed spirit due to phlegm-heat.;Inclusion criteria: 1. Signed the informed consent; 2. Aged between 18 and 60 years; 3. Subacute or chronic insomnia with one or more months duration; 4. Primary insomnia except for the familial fatal insomnia; 5. General score of Spiegel questionnaire is bigger than 9; 6. Syndrome differentiation is the disturbed spirit due to phlegm-heat.;Inclusion criteria: 1. Signed the informed consent; 2. Aged between 18 and 60 years; 3. Subacute or chronic insomnia with one or more months duration; 4. Primary insomnia except for the familial fatal insomnia; 5. General score of Spiegel questionnaire is bigger than 9; 6. Syndrome differentiation is the disturbed spirit due to phlegm-heat.;Inclusion criteria: 1. Signed the informed consent; 2. Aged between 18 and 60 years; 3. Subacute or chronic insomnia with one or more months duration; 4. Primary insomnia except for the familial fatal insomnia; 5. General score of Spiegel questionnaire is bigger than 9; 6. Syndrome differentiation is the disturbed spirit due to phlegm-heat.

Exclusion criteria

Exclusion criteria: 1. Not belong to the syndrome differentiation of disturbing spirit due to phlegm-heat; 2. General score of Self-Rating Anxiety Scale (SAS) is 50 or more; 3. General score of Beck Depression Rating Scale(BDI) is 14 or more; 4. Secondary insomnia, or insomnia caused by physical illness, such as Stroke, Parkinson's disease; 5. Participating in other clinical studies; 6. Pregnant, lactating, or preparing for pregnant women; 7. Have the tendency of default.;Exclusion criteria: 1. Not belong to the syndrome differentiation of disturbing spirit due to phlegm-heat; 2. General score of Self-Rating Anxiety Scale (SAS) is 50 or more; 3. General score of Beck Depression Rating Scale(BDI) is 14 or more; 4. Secondary insomnia, or insomnia caused by physical illness, such as Stroke, Parkinson's disease; 5. Participating in other clinical studies; 6. Pregnant, lactating, or preparing for pregnant women; 7. Have the tendency of default.;Exclusion criteria: 1. Not belong to the syndrome differentiation of disturbing spirit due to phlegm-heat; 2. General score of Self-Rating Anxiety Scale (SAS) is 50 or more; 3. General score of Beck Depression Rating Scale(BDI) is 14 or more; 4. Secondary insomnia, or insomnia caused by physical illness, such as Stroke, Parkinson's disease; 5. Participating in other clinical studies; 6. Pregnant, lactating, or preparing for pregnant women; 7. Have the tendency of default.;Exclusion criteria: 1. Not belong to the syndrome differentiation of disturbing spirit due to phlegm-heat; 2. General score of Self-Rating Anxiety Scale (SAS) is 50 or more; 3. General score of Beck Depression Rating Scale(BDI) is 14 or more; 4. Secondary insomnia, or insomnia caused by physical illness, such as Stroke, Parkinson's disease; 5. Participating in other clinical studies; 6. Pregnant, lactating, or preparing for pregnant women; 7. Have the tendency of default.;Exclusion criteria: 1. Not belong to the syndrome differentiation of disturbing spirit due to phlegm-heat; 2. General score of Self-Rating Anxiety Scale (SAS) is 50 or more; 3. General score of Beck Depression Rating Scale(BDI) is 14 or more; 4. Secondary insomnia, or insomnia caused by physical illness, such as Stroke, Parkinson's disease; 5. Participating in other clinical studies; 6. Pregnant, lactating, or preparing for pregnant women; 7. Have the tendency of default.

Design outcomes

Primary

MeasureTime frame
Spiegel sleep questionairy;Self rating Anxiety Scale;Beck self rating Depression Scale; Pittsburgh sleep quality index;Insomnia severity index;

Secondary

MeasureTime frame
Patient and doctor report outcome;

Countries

China

Contacts

Public ContactLiu Baoyan, He Liyun;Liu Baoyan, He Liyun;Liu Baoyan, He Liyun;Liu Baoyan, He Liyun;Liu Baoyan, He Liyun ;;;;

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Science;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Science;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Science;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Science;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Science

13601180524@139.com;13601180524@139.com;13601180524@139.com;13601180524@139.com;13601180524@139.com+86 13601180524;+86 13601180524;+86 13601180524;+86 13601180524;+86 13601180524

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026