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A randomized, double-blind, parallel controlled clinical study of tangerine peel enzyme in the treatment of insomnia with deficiency of heart and spleen

A randomized, double-blind, parallel controlled clinical study of tangerine peel enzyme in the treatment of insomnia with deficiency of heart and spleen

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005639
Enrollment
Unknown
Registered
2022-02-15
Start date
2020-07-08
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

insomnia

Interventions

Test group:Orange peel enzyme concentrated juice, 1 tube each time, twice a day, oral. Provided by Guangdong xinbaotang Biotechnology Co., Ltd
The course of treatment was 4 weeks.
control group:Tangerine peel enzyme simulant (the specification, appearance and packaging are the same as those of the test group), one at a time, twice a day, orally. Provided by Guangdong xinbaotang

Sponsors

Guangdong Hospital of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Over 18 years old. (2) The diagnosis of chronic insomnia meets the Western medical standard. (3) It meets the standard of deficiency syndrome of heart and spleen in traditional Chinese medicine. (4) Pittsburgh sleep quality index (PSQI) total score > 7 (5) Sign informed consent

Exclusion criteria

Exclusion criteria: (1) People who are ready for pregnancy or during pregnancy or lactation or need to sleep with their children. (2) According to the medical history and consultation, the doctor confirmed the secondary insomnia caused by other diseases. For example: local pain, restless legs syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis (3) Patients with moderate and severe depression (total score = 10) were diagnosed according to the patient's self rating depression tool (PHQ-9) (4) Patients with moderate and severe anxiety were diagnosed according to GAD-7 (total score = 10) (5) According to the medical history and consultation, the doctor confirmed that the patient needs to be managed according to the disease management mode.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep index scale total score;

Secondary

MeasureTime frame
Patient depression self assessment tool (PHQ-9);Generalized anxiety scale (GAD-7);Insomnia TCM quality of life scale (tcmqli-21);

Countries

china

Contacts

Public ContactJiaminYuan
13580355694@126.com13580355694

Outcome results

None listed

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