Study on New Scheme and Mechanism of Chronic Insomnia Diagnosis and Treatment: The clinical effect of SD-265 method on adults with insomnia that have difficulty in falling asleep (heart and gallbladder qi deficiency)

Study on New Scheme and Mechanism of Chronic Insomnia Diagnosis and Treatment: the clinical effect of SD-265 method on adults with insomnia that have difficulty in falling asleep (heart and gallbladder qi deficiency)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034002

Enrollment

Unknown

Registered

2020-06-20

Start date

2021-01-01

Completion date

Unknown

Last updated

2022-11-20

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

Conditions

Insomnia

Interventions

Experimental group:take Wendantang orally+smell the water-saturated Liquid Aroma of wendantang+Foot Soak + Sleep Cognition Guidance + Exercise + Light

Control group:take wendantang orally

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with difficulty in falling asleep as the main complaint and meeting the diagnostic criteria of primary insomnia; 2. Patients with unlimited gender, aged 20-60 years; 3. Patients who are conscious, can understand the contents of the scale and cooperate with the treatment; 4. Patients willing to accept the clinical observation and sign the informed consent; The selection of TCM syndrome type refers to the diagnosis of heart and gall deficiency syndrome in the diagnostic standard of common witness of traditional Chinese medicine formulated by the diagnostic branch of Chinese Medicine Society of Chinese medicine, and the following standards are formulated: insomnia and difficulty in falling asleep are the main symptoms, palpitation and timidity are also found, it is not easy to fall asleep, and it is easy to be frightened after falling asleep. When things happen, they are scared and tired. The tongue is light and white with fine veins.

Exclusion criteria

Exclusion criteria: 1. Patients who have not been effectively controlled or have serious diseases, such as persistent pain caused by various reasons, malignant tumors, cardiovascular and cerebrovascular diseases, neuroendocrine diseases and other secondary insomnia; 2. Patients with severe anxiety and depression, psychosis; 3. Pregnant and lactating patients; 4. Patients participating in other clinical observation; 5. Patients with communication disorders (for patients who plan to use cognitive therapy); 6. Patients with photosensitive history; 7. Patients with foot skin lesions; 8. Patients who are not suitable for clinical trials for other reasons.

Design outcomes

Primary

Measure	Time frame
Data of Instrument body motion;SD-265 patient self-assessment form;	—

Secondary

Measure	Time frame
PSQI scale score;ISI scale score;	—

Countries

China

Contacts

Public ContactYe Yongming

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

huanyym@126.com+86 10-60283731

Outcome results

None listed

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