Randomized Clinical Trial on Aromatherapy combined with Ointment Therapy in Chronic Insomnia of Heart-Kidney Disharmony Type
- Conditions
- Insomnia
- Registration Number
- ITMCTR2200006830
- Lead Sponsor
- Dongzhimen Hospital, Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1)18 years old = 80 years old, gender not limited;(2)Conforming to Chinese medicine'Insomnia' diagnostic criteria and 'disharmony of heart and kidney' syndrome diagnostic criteria;(3)Consistent with Western medical criteria for?the diagnosis of?non-organic chronic insomnia;(4)Cumulative score of 7 factors in PSQI > 7;(5)Patients who did not participate in clinical trials of other drugs;(6)Volunteer to participate in this experiment and sign the informed consent form.
(1)Insomnia related to work and living environment, such as working or living across time zones, environment or work reasons can not ensure adequate sleep time;(2)Take any antibiotics and glucocorticoids in recent 3 months;(3)Patients with systemic diseases such as pain, fever, cough, surgery, etc.;(4)Patients with severe primary diseases such as severe respiratory, circulatory, digestive, urinary, hematopoietic and endocrine systems, and psychiatric patients;(5)Allergic individuals or known to be allergic to a drug in a treatment plan;(6)Alcoholics and/or users of psychoactive drugs, drug abusers and addicts;(7)Pregnant or lactating women;(8)Other situations that the researcher considered unsuitable for inclusion.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PSQI;TCM syndrome score;
- Secondary Outcome Measures
Name Time Method Sleep monitoring ring index;SAS;SDS;FS-14;MEQ-19;PFS-R;