Chinese Medicine in Treating Insomnia

NCT06511011 | Recruiting Phase 2 DMC

• 1 other identifier: Insomnia study
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blinded, placebo-controlled clinical trial. Eligible participants will randomized into either treatment group (CM granules) or placebo group (placebo granules) for 6 weeks, followed by a post-treatment visit at week 9. The primary outcome is the change in Pittsburgh Sleep Quality Index (PSQI) at week 6.

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• The change in Pittsburgh Sleep Quality Index (PSQI)

  PSQI, which is a self-reported instrument, is commonly used in assessing the sleep quality in many studies. It consists of 19 items, covering seven domains, including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. PSQI items use varying response categories that include recording usual bed time, usual wake time, number of actual hours slept, and number of minutes to fall asleep, as well as forced-choice Likert-type responses (scoring from 1-4, which 1 indicates the best and 4 indicates the worst).

  Week 6

Secondary Outcomes (9)

• The change in Pittsburgh Sleep Quality Index (PSQI)

  Week 3

• The change in Pittsburgh Sleep Quality Index (PSQI)

  Week 9

• Sleep parameter data

  From baseline to week 9.

• The change in Insomnia Severity Index (ISI)

  Week 3

• The change in Insomnia Severity Index (ISI)

  Week 6

Study Arms (2)

mSZT-TBD granules

EXPERIMENTAL

Modified Suan ZaoRen Tang-TianWang BuXin Dan granules

Drug: Modified Suan ZaoRen Tang-TianWang BuXin Dan

Placebo granules

PLACEBO COMPARATOR

Placebo granules

Drug: Placebo

Interventions

Modified Suan ZaoRen Tang-TianWang BuXin Dan DRUG

Chinese medicine granules for 6 weeks

Also known as: mSZT-TBD

mSZT-TBD granules

Placebo DRUG

Placebo granules for 6 weeks

Also known as: Placebo granules

Placebo granules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years;
• Eligible for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, criteria for insomnia disorder. The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 nights per week for at least 6 months;
• Insomnia Severity Index (ISI) total score of at least 8 indicating insomnia at the clinical level;
• Diagnosed to be Yin deficiency-induced internal heat pattern according to traditional Chinese Medicine (TCM) theory;
• Able to complete questionnaires and take medications as scheduled; and
• Voluntary written consent.

You may not qualify if:

• Known nervous system disease (eg, stroke, Parkinson's Disease);
• Known mental disorders (eg, depression or anxiety) or HADS score 11 or above in any either item;
• Known sleeping related diseases (eg. sleep apnea, nocturnal myoclonus, restless legs, severe nocturnal enuresis or narcolepsy) that may affect the sleeping quality;
• Known pharmacologically induced insomnia;
• With symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturition, and cough;
• Know treatment to comorbid sleep disorders, such as sleep apnea or narcolepsy;
• Work on shift or on night shift;
• Concomitant pharmacological treatment or herbal medicines for insomnia within the past month;
• Known severe medical conditions, such as cardiovascular, liver, kidney or hematopoietic system disease, diabetes mellitus, cancers, cerebrovascular diseases;
• Impaired hematological profile and liver / renal function exceeds the upper limit of the reference value by 2 times;
• Known alcohol and / or drug abuse;
• Known allergic history to any Chinese herbal medicines;
• Diagnosed to be deficiency of spleen according to TCM theory;
• Any contraindications for taking Chinese medicines in the opinion of the investigators;
• Know pregnant or lactating; and

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Hong Kong Institute of Integrative Medicine

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Zhixiu Lin

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhixiu Lin

CONTACT

39436347; linzx@cuhk.edu.hk

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: September 25, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)