Clinical trial
Investigation of Huatuo Zaizao Pill in Treating Phlegm and Blood-stasis Blocking Collaterals Pattern of Ischemic Stroke Patients: Study Protocol for a Randomized Controlled Trial
Name
XiyuanH-huatuo zaizao pill
Description
This study is aiming to evaluate the efficacy and safety of Huatuo Zaizao pill in ischemic stroke patients who diagnosed as the phlegm and blood-stasis blocking collaterals syndrome in TCM. A total of 80 subjects will be randomly assigned to Huatuo Zaizao pill group or the control group.
Trial arms
Trial start
2021-06-01
Estimated PCD
2024-06-20
Trial end
2024-10-20
Status
Recruiting
Phase
Early phase I
Treatment
HuaTuo Zaizao pill
Patients take 8g of HuaTuo Zaizao pill three times a day. Treatment lasts for 12 weeks.
Arms:
HuaTuo ZaiZao group
basic treatment
It accordance with the "Guidelines for diagnosis and treatment of ischemic stroke in China",and the drug and dosage will be formulated by the researchers according to the clinical situation.
Arms:
Control group, HuaTuo ZaiZao group
Size
80
Primary endpoint
National Institute of Health Stroke Scale (NIHSS )
The change from baseline in National institute of health stroke scale (NIHSS ) score at week 6 and 12 [Time Frame: Baseline,6th week±3 days, 12th week±3 days]
Eligibility criteria
Inclusion Criteria:
* 1.Aged between 35 and 75 years old 2.With a disease course between 2 weeks- 24weeks 3.Meeting the diagnostic criteria of ischemic stroke 4.Meeting the diagnostic criteria of phlegm and blood-stasis blocking collaterals pattern in T traditional Chinese medicine 5.Signed and dated written informed consent. 6.4≤NIHSS score≤22
Exclusion Criteria:
* 1.Unstable vital signs, or serious heart, liver, lung, kidney and other organ diseases 2.Exclude Transient Ischemic Attack(TIA) 3.Patients who are participating in clinical trials of other drugs within the past 1 month 4.Pregnant or breastfeeding women 5.Athletes, Epileptics, Allergic to this product
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Participants are randomly and evenly assigned to 2 groups using block randomization.Random numbers are generated by the stratified random method using the Statistical Analysis Software （SAS） statistical software and assigned by an independent statistician at the Good Clinical Practice Institute of XiYuan Hospital.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-05-03
1 organization