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Clinical efficacy and safety of Chaixiong Qiwei formula for Tension-type Headache

Capital's Funds for Health Improvement and Research

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042514
Enrollment
Unknown
Registered
2021-01-22
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-03

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

Conditions

Tension-type Headache

Interventions

Sponsors

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients meeting the diagnostic criteria of frequent tension type headache; 2. Subjects whose first onset age was less than 50 years old; 3. Subjects with a course of more than 3 months and a headache duration of more than 5 days in the previous month; 4. Subjects aged 18-65 years; 5. Subjects who signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Other subtypes of tension type headache, migraine, cluster headache and other causes of headache; 2. Patients with headache caused by systemic diseases, such as cardiovascular diseases, acute infectious diseases, blood diseases, endocrine and metabolic diseases, allergic reactions, poisoning, etc; 3. Headache caused by facial diseases, such as glaucoma, otitis media, sinusitis, pericoronitis of wisdom teeth, etc; 4. Headache caused by intracranial organic diseases, such as intracranial infection, brain tumor, subarachnoid hemorrhage, etc; 5. Anxiety disorder, Hamilton Anxiety Scale (HAMA) >= 14 points; 6. Depression, Hamilton Depression Scale (HAMD) >= 17 points; 7. Patients with abnormal liver and kidney function, 2 times or more than the normal value; 8. Patients identified as alcohol or drug dependence in the past 6 months; 9. Patients with nervous system diseases that can affect cognitive function, such as Alzheimer's disease, severe Parkinson's disease, encephalitis, etc; 10. Preparation of pregnant, lactating and pregnant women; 11. Subjects who are allergic to the components of traditional Chinese medicine used in this study protocol; 12. Subjects participating in other clinical trials; 13. Subjects who could not comply with the study protocol.

Design outcomes

Primary

MeasureTime frame
Days of headache reduction;

Secondary

MeasureTime frame
Days of headache;Headache intensity;Treatment efficiency;Emergency drug use;Quality of life assessment;Observation table of TCM symptoms of tension type headache;

Countries

China

Contacts

Public ContactZhang YunLing

Xiyuan Hospital, Chinese Academy of traditional Chinese Medicine

yunlingzhang2004@163.com+86 13910764257

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026