Chinese Medicine in Treating Insomnia

Phase 2

Not yet recruiting

• Conditions: Insomnia Chronic
• Interventions: Drug: Modified Suan ZaoRen Tang-TianWang BuXin Dan; Drug: Placebo

• Registration Number: NCT06511011
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Insomnia is one of the most general health concerns in the society. It is generally defined as a self-reported sleep disorder problem of the patient, characterized by difficulty in falling asleep, or difficulty maintaining sleep. According to American Insomnia Survey, 42.6% of the respondents reported of having at least one of the insomnia symptoms.

Chinese medicine can be an alternative to the treatment of insomnia. Suan Zao Ren Tang and Tian Wang Bu Xin Dan are two of the most common Chinese herbal formulae to treat insomnia, for which Suan Zao Ren Tang has the functions to nourish blood and calm the mind, clear heat and alleviate vexation, and Tian Wang Bu Xin Dan has the function to nourish the heart and calm the mind, and nourish Yin and clear heat. In this study, we will modify the formula of Suan ZaoRen Tang with TianWang BuXin Dan, and observe the effectiveness and safety of the study drug.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Study Start: 2024-09
• Primary Completion: 2026-05
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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
• Involved in other interventional clinical studies at the same time.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mSZT-TBD granules	Modified Suan ZaoRen Tang-TianWang BuXin Dan	Modified Suan ZaoRen Tang-TianWang BuXin Dan granules
Placebo granules	Placebo	Placebo granules

Primary Outcome Measures

Name	Time	Method
The change in Pittsburgh Sleep Quality Index (PSQI)	Week 6	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).

Secondary Outcome Measures

Name	Time	Method
The change in Pittsburgh Sleep Quality Index (PSQI)	Week 9	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).
Sleep parameter data	From baseline to week 9.	Wrist actigraphy, which is a small size monitor, is an alternative to objectively measure the sleep patterns of subjects, the measuring parameters include sleep onset latency (SOL), wake time after sleep onset (WASO), total sleep time duration (TST), total time in bed (TIB), and sleep efficiency (SE). The actigraph will be recorded using Philips Actiwatch 2.
The change in Insomnia Severity Index (ISI)	Week 9	ISI is a self-reported questionnaire to assess both daytime and nighttime components of insomnia. It consists of seven items to evaluate the severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28
The change in Hospital Anxiety and Depression Scale (HADS)	Week 9	HADS consists of 7 depression items and 7 anxiety items which measures the cognitive and emotional aspects of depression and anxiety. The scale is a 4-point Likert scale, ranging from 0 -3. Score range. 0 - 42 for the total score; 0 -21 for the HADS-Anxiety and HADS-Depression.