A randomized controlled clinical study on the efficacy and safety of Tianshu capsule in the treatment of anxiety headache

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-16008798

Enrollment

Unknown

Registered

2016-07-07

Start date

2016-07-01

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

anxiety headache

Interventions

Experimental group:Deanxit+Tianshu capsule

control group:Deanxit+Zhengtian pill

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) meet diagnostic criteria of anxiety disorder in Diagnostic and Statistical Manual of Mental Disorders: DSM-V; (2) Hamilton Anxiety Scale (HAMA) score more than 14 points, Self-Rating Anxiety Scale (SAS) score of 50-59 points; (3) the age of 18-65 years; (4) meet diagnostic criteria of migraine or tension headache in International Classification of Headache Disorders (ICHD-III beta); (5) headache attack 2-8 times in the four weeks of screening period; (6) headache attack less than 15d in the four weeks of screening period; (7) be able to understand and complete pain diary; (8) patients agree to sign clinical use informed consent.

Exclusion criteria

Exclusion criteria: (1) score of HAMA in the screening period decreases more than 25% compared to baseline; (2) exclude patients of cluster headache, non-migraine vascular headache, drug dependence headache, secondary headache; (3) continuous use of migraine medications, anti-psychotic or anti-depressive agents within the 3 months before the baseline period; (4) taking Tianshu capsules or Zhengtian pills within the month before the baseline period; (5) taking anodynes more than 10 times for headache every month; (6) resistant to acute pain relief drugs; (7) alcohol or other drug abusers; (8) combined cardiovascular, brain, liver, kidney, hematopoietic system or other serious diseases, severe infections, malignant tumors, or other diseases that may have an impact on the test; (9) preparing pregnant, pregnant or lactating women; (10) allergy to test drugs; (11) unable to coordinate with doctors completing the scales or pain diary; (12) participate in other clinical researches.

Design outcomes

Primary

Measure	Time frame
Hamilton Anxiety Scale;Self-Rating Anxiety Scale;Pain diary;Self-reporting Inventory;	—

Countries

China

Contacts

Public ContactYUN XU

Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing

xuyun20042001@aliyun.com+86 025 83105208

Outcome results

None listed

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