To clarify the clinical effects of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke and to explore the possible mechanism. Participants will take the granules of Shengdi Dahuang Decoction that contains 15 grams of rehmannia and 5 grams of rhubarb, one pack per time, twice a day for 7 days.

To explore the effective clinical therapy in acute hemorrhagic stroke. Participants will take placebo contains 2% rehmannia and rhubarb, one pack per time, twice a day for 7 days.

Hemorrhagic Stroke

Shengdi Dahuang Decoction contains Shengdi (rehmannia) and Dahuang ( rhubarb). Each pack of the granules of Shengdi Dahuang Decoction contains 15 grams of rehmannia and 5 grams of rhubarb.

Granules of Shengdi Dahuang Decoction

Placebo granules has the same appearence, weight, shape and color as the experimental drug.

Placebo

Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM

Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong University

Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

Shuguang Hospital affiliated with Shanghai University of TCM

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

A Randomized, Controlled, Double-blind, Multi-center Clinical Study of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

Modified Rankin Scale score (mRS) will be graded on the 90th day after onset (mRS score ranges from 0 point (no symptoms at all) to 5 points (severe disability)).

The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.

The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.

National Institute of Health Stroke Scale (NIHSS) will be used to assess the severity of neurological deficit on the 7th day after treatment. NIHSS score ranges from 0 point to 42 points. More severe neurological deficit could be observed in participants with the higher score.

All participants will reexamine the skull CT scan 24 hours after onset. The volume of hematoma (ml) increases more than 6ml or 33% relative increment than original volume is defined as the expansion of hematoma. The proportion of hematoma enlargement cases (%) will be compared between different groups.

All participants will reexamine the skull CT scan on the 7th day after treatment. The volume (ml) of edema and hematoma will be calculated respectively. The ratio of edema volume and hematoma volume represents the severity of edema.

Xiaofei Yu

Clinical Professor

ShuGuang Hospital

This arm is an control group,in which participants will receive conventional integrated therapy on CRF.

This arm is a treatment group,in which participants will receive integrated therapy on CRF and traditional Chinese medicine Colonic dialysis with traditional Chinese medicine colon lotion once a day.

Chronic Kidney Failure

End-Stage Kidney Disease

The colon lotion used in this clinic trial is a kind of hospital preparation. It is brown liquid,which consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The colon lotion is diluted from 30ml to 150ml each time and will be used once a day for 10 days.

colon lotion

Guangdong Provincial Hospital of Traditional Chinese Medicine

Traditional Chinese Medicine (TCM) Colon Dialysis Treats Non-dialysis End-Stage Kidney Disease

Clinical Observation of Therapeutic Effects on Traditional Chinese Medicine Colon Dialysis Treating Non-dialysis End-Stage Kidney Disease

measuring the level of urea nitrogen，blood urea nitrogen,serum creatinine, serum cystatin C, blood and urineβ2-microglobulin. calculating the creatinine clearance rate.

measuring serum endotoxin and investigating the differences of intestinal flora between control group and experience group，as well as the differences between before colonic dialysis and after colonic dialysis.

measuring serum contents of sodium，potassium and phosphorus.

measuring hs-C reactive protein(hs-CRP),interleukin 1β(IL-1β)，IL-6，tumor necrosis factor α(TNF-α) in serum.

measuring platelet derived growth factor (PDGF) secretion and serum transforming growth factor β(TGF-β).

Besides personal privacy information of the patients, all the other individual patient data（IPD）that treatment related will be shared with other researchers.After articles of this study publishing,researchers can obtain the information from the articles or sending e-mail to us.

rhubarb/mantar

Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

Traditional Chinese Medicine (TCM) Colon Dialysis Treats Non-dialysis End-Stage Kidney Disease

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