Clinical Evaluation of Herbal Medicine (ICH-012)‎ in Treating Acute Cerebral Haemorrhage: Safety and Efficacy from 6- to 72-Hour Time Window (CRRICHTrial-II)‎

الملخص EN

Background.

Hypertensive intracerebral haemorrhage (HICH), which is characterized by rapid change, high morbidity, and mortality, is extremely dangerous.

Both medical and surgical treatments lack definitive evidence and remain controversial.

A prospective RCT that we have conducted has shown that the usage of the herbal medicine ICH-012 within 6 h of the event may increase the risk of haematoma enlargement and gastrointestinal bleeding.

However, the volume of haematoma remains stable after 6 h.

Thus, we will increase the time window to the period from 6 to 72 h after onset to evaluate the safety and efficacy of ICH-012 treating ICH (ClinicalTrial.gov ID: NCT03354026).

Methods/Design.

The CRRICHTrial-II study, a prospective, double-blinded, controlled, multicentre RCT, includes three groups: A, B, and C.

Group A patients were treated with 8 herbal medicines (with 2 herbal medicines of Hirudo and Tabanus as well as 6 other combined herbal medicines of Group B) and Group C were placebo.

Patients should meet all the inclusion criteria: age between 18 and 80 and diagnosis of HICH by brain CT scan between 6 and 72 h from the onset.

The CT scan will be taken at four critical time points: baseline, between 6 and 72h, 24h after onset, and between 10 and 14 days after onset.

The drug intervention lasts 10 days, and there is a follow-up visit taken after 90 days.

The haematoma enlargement after 24 h onset as demonstrated by CT is the primary outcome.

Discussion.

A large amount of data from high-quality RCTs is needed for the extensive clinical application of herbal medicine.

The CRRICHTrial-II will evaluate the safety and effectiveness of ICH-012 in a safer time window between 6 and 72 h and investigate the possible mechanisms of action and direction of herbal medicine in the haematoma growth after HICH.

Trial registration at ClinicalTrial.gov, ID: NCT03354026, is registered on 23rd Nov.

2017.