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Randomized Clinical Trial on Aromatherapy combined with Ointment Therapy in Chronic Insomnia of Heart-Kidney Disharmony Type

Randomized Clinical Trial on Aromatherapy combined with Ointment Therapy in Chronic Insomnia of Heart-Kidney Disharmony Type

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006830
Enrollment
Unknown
Registered
2022-11-27
Start date
2022-11-25
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Insomnia

Interventions

Group A(Control Group):Zhenzhong ointment
Group B:Aromatherapy+Zhenzhong ointment
Group C:Jianpizhenzhong ointment

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

MeasureTime frame
PSQI;TCM syndrome score;

Secondary

MeasureTime frame
Sleep monitoring ring index;SAS;SDS;FS-14;MEQ-19;PFS-R;

Countries

China

Contacts

Public ContactShi Yi
docjoyshi@163.com13661152451

Outcome results

None listed

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