A Phase III Clinical Trial of Huanglianejiao Capsule

Efficacy and Safety of Huanglianejiao Capsule on Chronic Primary Insomnia (Syndrome of Exuberant Fire due to Yin Deficiency): a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15007222

Enrollment

Unknown

Registered

2015-10-16

Start date

2015-11-16

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Chronic Primary Insomnia

Interventions

Treatment Group :Huanglianejiao capsule

Placebo Group :Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants diagnosed with primary insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-IV-TR); 2. Participants diagnosed with chronic primary insomnia based on expert consensus; 3. Participants diagnosed with syndrome of exuberant fire due to yin deficiency; 4. Participants with both of the following conditions for more than or equal to 5 days in sleep diaries before randomized: (1) Total sleep time is less than or equal to 6.5h; (2) Time to fall asleep taking more than or equal to 30 minutes. 5. Participants with HAMD-17 less than 7; 6. Participants with HAMA-17 less than 14; 7. Participants aged 18~75.

Exclusion criteria

Exclusion criteria: 1. Participants with symptoms that significantly disturb sleep; 2. Working and living environment cannot be guaranteed in a fixed residence and adequate opportunity to sleep (bedtime at least 8 h); 3. Participants having serious heart, nervous, liver, kidney, endocrine, blood system and other body disease; 4. Participants having depression, anxiety, schizophrenia and other serious mental disorders; 5. Having sleep apnea syndromes; 6. Professional drivers or high-altitude operators; 7. Allergic to pharmaceutical ingredients; 8. Pregnancy or breast-feeding women; 9. Using alcohol and/or mentally active drug, drug abuse and dependence, extensive use of nicotine and/or caffeine; 10. Using drugs for the treatment of insomnia; 11. Participants with family history of mental illness.

Design outcomes

Primary

Measure	Time frame
Total Sleep Time( Subjective );	—

Secondary

Measure	Time frame
Sleep Latency( Subjective );Total Number of Awakenings( Subjective );Pittsburgh Sleep Quality Index;PSG;Digit Symbol Substitution Test;TCM Efficacy;	—

Countries

China

Contacts

Public ContactShi Jing

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

shijing87@hotmail.com+86 010-84013132

Outcome results

None listed

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