Effects of the modified TianWang buxin granule and modified TianWang buxin decoction pieces on insomnia: a randomized, controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-17011549

Enrollment

Unknown

Registered

2017-06-02

Start date

2017-06-15

Completion date

Unknown

Last updated

2017-06-05

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

Conditions

insomnia

Interventions

Granule group :modified Tianwang Buxin Granule

decoction pieces group:modified Tianwang Buxin decoction pieces

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The main symptom is insomnia and meets the diagnosis of insomnia; 2. According with the manifestations of insufficiency of heart-yin : sleepless, palpitations, fatigue, red tongue, thready pulse; 3. Aged 18-65 years old; 4. All patients involved in this study must sign informed consents. Those who meet all the above conditions can be selected into the study.

Exclusion criteria

Exclusion criteria: 1. Secondary insomnia caused by serious illness; 2. Patients with severe anxiety , depression or mental disease; 3. Pregnant or lactating patients. Those who meet any one of the above conditions would be excluded.

Design outcomes

Primary

Measure	Time frame
TCM syndrome score;Pittsburgh sleep quality index (PSQI);the scores of fatigue scale-14 (FS-14);the scores of Athens insomnia scale (AIS);Insomnia Severity Index (ISI);the scores of Hamilton's depression scale (HAMD);the scores of Hamilton's anxiety scale (HAMA);clinical efficacy;sleep efficiency;	—

Secondary

Measure	Time frame
sleep diaries;	—

Countries

China

Contacts

Public ContactLing Liu

Hubei University of Chinese Medicine

lingliu07199@aliyun.com+86 18971537282

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026