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

Phase 1
Conditions
Tension-type Headache
Registration Number
ITMCTR2200006020
Lead Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
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

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.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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