A Series of N-of-1 Randomized Trials of Chaixiong Qiwei formula for Tension-type Headache.

This research was supported by the National TCM Leading Personnel Support Program (NATCM Personnel and Education Department (2018)) (No. 12)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200006020

Enrollment

Unknown

Registered

2022-05-19

Start date

2022-05-19

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Tension-type Headache

Interventions

Interventional group: ChaiXiong QiWei formula

control group:placebo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients must meet the diagnostic criteria of Chronic tension- type headache;2.Clinical findings of CTTH for= 3 months and the number of TTH days=15 days in the previous month before screening;3.The onset of TTH should have happened before the age of 50 years;4.Patients aged between 18 and 65 years;5.Participants voluntarily participated in this study, signed informed consent.

Exclusion criteria

Exclusion criteria: 1.TTH combined with migraine, cluster headache and other causes of headache;2.TTH with regular overuse of acute or symptomatic headache medication, including regular intake of drugs on=10 days/month for opioids and combination analgesics and on=15 days/month for paracetamol (also known as acetaminophen),acetylsalicylic acid and NSAID;3.Patients with severe liver and kidney dysfunction;serum transaminase levels and creatinine more than double the normal value;4.Patients combined with severe disease such as cardiovascular, nervous system, digestive system or hematopoietic system;5.Patients who have experienced alcohol or drug dependence in the last 6 months before screening;6.Patients with nervous system diseases affecting cognitive function, such as Alzheimer's disease, severe Parkinson's disease, encephalitis, etc;7.Patients who are pregnant or lactating, preparing for pregnancy during the trial;8.Patients who are allergic to research drugs and its ingredients( such as Bombyx batryticatus);9.Subjects participating in other clinical trials;10.Researchers estimate that the patient unable to complete the study.

Design outcomes

Primary

Measure	Time frame
Days of headache;Intensity of headache;	—

Secondary

Measure	Time frame
Quality of life assessment;Observation table of TCM symptoms of tension type headache;Hamilton's Depression Scale(HAMD);Hamilton Anxiety Scale(HAMA);Drug consumption for acute treatment;Responder rate;	—

Countries

China

Contacts

Public ContactZhang YunLing

yunlingzhang2004@163.com+86 13910764257

Outcome results

None listed

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