TABLE 2.
Clinical trials on the active ingredients of Tripterygium wilfordii Hook F.
| Name | Condition or disease | ClinicalTrials.gov number | Sponsor | Interventions | Primary outcomes | Phase |
|---|---|---|---|---|---|---|
| Tripterygium Wilfordii Hook F | IgA Nephropathy | NCT02187900 | Second Xiangya Hospital of Central South University | TwHF/Mycophenolate mofetil (MMF) | 1.Number of patients reaching remission | Phase 3 |
| 2.Renal survival | ||||||
| Rheumatoid Arthritis | NCT04136262 | Guang’anmen Hospital of China Academy of Chinese Medical Sciences | Tripterygium wilfordii Hook F (TwHF)/Methotrexate | 1.Percentage of ACR20 | Phase 3 | |
| 2. Percentage of ACR50 | ||||||
| 3. Percentage of ACR70 | ||||||
| 4. RAMRIS score | ||||||
| Human Immunodeficiency Virus | NCT01666990 | Beijing 302 Hospital | TwHF/Placebo treatment | 1.The total CD4 T cell counts compared with CD4 T cell counts at baseline 2.The CD38 expression on CD8 T cells | Phase 2 | |
| Arthritis, Rheumatoid | NCT01613079 | Peking Union Medical College Hospital | Tripterygium wilfordii Hook F/Methotrexate | 1. The proportion of patients achieving ACR50 | Phase 3 | |
| 2. Radiology outcome | ||||||
| 3. DAS28 | ||||||
| 4. ACR20/70 | ||||||
| Nephritis, Lupus | NCT01646736 | Peking Union Medical College Hospital | Tripterygium wilfordii Hook F/Cyclophosphamide/GC | 1. The proportion of patients achieving Complete Response (CR) and Partial Response (PR) | Phase 3 | |
| 2. Renal Function | ||||||
| 3. Serum Albumin Level | ||||||
| Rheumatoid Arthritis | NCT03337815 | Guang’anmen Hospital of China Academy of Chinese Medical Sciences | MTX and TwHF placebo/TwHF and MTX placebo | 1.The change in Disease Activity Score (DAS28) | Phase 3 | |
| 2. The proportion of patients achieving ACR20/50/70 | ||||||
| HIV | NCT02002286 | LI Taisheng, Peking Union Medical College | Tripterygium Wilfordii Hook F extrac | 1. Changes of T cell subsets and immune activation markers | Not Applicable | |
| 2. Viral load | ||||||
| 3. Number of participants with adverse events as a measure of safety and tolerability | ||||||
| Topical tripterygium gel | Arthritis, Rheumatoid | NCT02818361 | Guang’anmen Hospital of China Academy of Chinese Medical Sciences | Topical tripterygium gel/Placebo gel | 1.Twenty percent improvement in the American College of Rheumatology criteria | Not Applicable |
| 2.Twenty percent improvement in the American College of Rheumatology criteria | ||||||
| Active Rheumatoid Arthritis | NCT01961505 | Guang’anmen Hospital of China Academy of Chinese Medical Sciences | Topical compound Tripterygium/Placebo | 1.ACR20 criteria | Not Applicable | |
| 2. ACR50 criteria | ||||||
| 3. 28-joint count Disease Activity Score | ||||||
| Tripterygium glycosides | Inflammatory Bowel Diseases, Crohn’s Disease | NCT02044952 | Zhu Weiming, Jinling Hospital, China | Tripterygium glycosides/Mesalazine | 1.Therapeutic effect measured by Crohn’s Disease Activity Index (CDAI) | Phase 3 |
| 2. The Side effects of Tripterygium wilfordii | ||||||
| Early Ankylosing Spondylitis | NCT00889694 | Sun Yat-sen University | Tripterygium/Sulfasalazine/placebo | 1. ASAS20 | Phase 3 | |
| 2. BASDAI20/50/70 | ||||||
| Lupus Nephritis | NCT00881309 | Nanjing University School of Medicine | Tripterygium | 1.Complete remission rate | Not Applicable | |
| 2.Renal relapse | ||||||
| 3. Partial remission | ||||||
| Diabetic Nephropathy | NCT00518362 | Nanjing University School of Medicine | Tripterygium | 1.To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy | Not Applicable |