One dosage of Chinese herbal medicine by oral administration per day for 8 weeks. For patients who cannot take oral medicine can be switched to colon route by the colonic therapy system（IMS-100A produced by Sunny Medical in Beijing China).

Patients in the control group only receive the standard medical treatment (SMT), no control drug with CHM.

Acute on Chronic Liver Failure

Traditional Chinese Medicine

Hepatitis B

One dosage of CHM includes Artemisiacapillaris Thunb (30g), Salvia miltiorrhiza Bge (30g), Rhizoma Atractylodis Macroce- phalae (30g), Rubia cordifolia L (30g), Sieyesbeckiaorientalis L (30g). Paeoniae Radix Rubra (60g), Gardenia jasminoides Ellis (9g), Hedyotis diffusa Willd (30g) and Bletilla striata (15g) are involved for excess syndrome, and Astragalus membranaceus (30g), Radix Pseudostellariae (15g), Radix Aconiti Lateralis Praeparata (10g), Galli Gigeriae Endothelium Corneum (20g), Polygonum cuspidatum Sieb.et Zucc (15g) are involved for deficiency syndrome.

Chinese herbal medicine

SMT therapy includes a high-calorie diet; nucleoside analogues for HBV DNA-positive patients; sodium restriction, diuretics and paracentesis combined with albumin infusion for ascites; lactulose and L-ornithine aspartate and lactulose for HE and hyper-ammonia; hemostatic treatment for gastrointestinal hemorrhage; antibiotics for infections and renal replacement for HRS and uremic symptoms.

Control (blank)

302 military hospital of China

Beijing Ditan hospital

Beijing youan hospital

Fuzhou infectious hospital

Xiamen hospital of traditional Chinese medicine

Hubei hospital of traditional Chinese medicine

Tongji hospital, Huazhong university of science and technology

The first affiliated hospital of Hunan university of traditional Chinese medicine

Jilin hepatology hospital

The sixth people's hospital of Shenyang

Shanghai public health clinical center

Shuguang hospital, Shanghai university of traditional Chinese medicine

Chengdu public health clinical center

The second people's hospital of Tianjin

Hangzhou Xixi hospital

Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment

Study on the Optimal Strategy for Acute-on-chronic Liver Failure Combined With Traditional Chinese and Modern Medicine: a Multi-center, Randomized and Controlled Study

transplant free survival at the time point of week 12

transplant free survival at the time point of week 24

compare the MELD score between the two arms. MELD is the abbreviation of model for end-stage liver disease involving serum bilirubin, creatinine, international normalized ratio (INR) and sodium.

compare the Child-Pugh score between the two arms. Child-Pugh score is the panel involving the serum bilirubin, coagulation function, albumin and the complication of hepatic encephalopathy and ascites.

compare the life quality based on WHOQOL-BRIEF between the two arms

incidence of liver related complications of the two arms including infections, encephalopathy, hepatorenal syndrome (HRS), and gastrointestinal bleeding.

Man Gong

Professor

Beijing 302 Hospital

Beijing YouAn Hospital

ShuGuang Hospital

Sun Yat-sen University

Huazhong University of Science and Technology

Fuzhou Infectious Hospital

Public Health Clinical Center of Chengdu

Hepatology hospital of Jilin Province

Shanghai Public Health Clinical Center

Guangxi University of Chinese Medicine

Hubei Hospital of Traditional Chinese Medicine

Beijing Ditan Hospital

Shenzhen traditional Chinese medical hospital

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Shenzhen Third People's Hospital

Tianjin Second People's Hospital

Group A: Placebo group (n = 10)
Supplement appearing similar to Herbal formulations
Each placebo tablet will contain microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating.
Dose: subjects in this group will take 4 placebo tablets per day

Group B: R. cordifolia group (n = 10)
2,000 mg R. cordifolia per day - supplied by Banyan Botanicals and following standard supplementation doses on commercially available supplement (https://www.banyanbotanicals.com/manjistha-tablets/)
Each tablet contains 500 mg of R. cordifolia per tablet.

Group C: Triphala group (n= 10)
Tablets of Triphala will be supplied from Banyan Botanicals (https://www.banyanbotanicals.com/triphala-tablets-11/)
Each tablet contains mix Emblica officinalis, Terminalia bellerica, and Terminalia chebula
Dose: subjects will take 4 tablets per day, with a total dose of 2,000 mg of total herb.

Sebum Production

Stool Microbiome

Transepidermal Water Loss

Facial Brrightness

Erythema

Wrinkles

Facial Shine

Placebo Oral Tablet

Rubia Cordifolia

Triphala

University of California-Davis, Department of Dermatology

Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin

Pilot Study on the Effects of Oral Triphala and Rubia Cordifolia on the Gut Microbiome and Skin Biophysical Properties

Stool microbiome diversity via stool sample

Facial brightness measured via photographic assessment

Facial redness via photographic assessment

Facial wrinkles via photographic assessment

We will assess digestive symptoms such as stooling patterns and regularity based on level of frequency (Never, Sometimes, Always, Unsure).

We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure).

We ask for a food diary that will account for all food and drink intake in a given day for three days prior to their next visit. The diary will note what food/beverage and how much of that item was consumed.

We do not plan to share individual patient data.

University of California, Davis

Thirty (30) subjects meeting the inclusion criteria without any of the exclusion criteria will be enrolled in this study. This study will be a double blinded study. Each subject will be randomized a priori to receive either placebo, Rubia cordifolia, or Triphala tablets.

rubia/inflammatie

Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment

Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin

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