Four Astragalus clinical trials on going in June 2022
What is Astragalus?
Astragalus root has long history as tonic in Traditional Chinese Medicine, it is kind of affordable ginseng in Ancient China. Astragalus plays a vital important role in TCM both in history and modern time, Astragalus is applied in both herb medicine and prescriptions. And the Astragalus extract brings more chances for both China pharmaceutical industry and the nutraceuticals industry outside China. Therefore, most of the clinical trials on Astragalus are in China.
In a modern view, Astragalus is considered an adaptogen. Astragalus roots are full of polysaccharides, saponins and flavonoids, they stimulate the immune system and reduce swelling. Researches and studies on Astragalus are performed as it is an important natural ingredient for the dietary supplements and functional foods.
The four ongoing Astragalus clinical studies in June 2022.
Today, we focus on the on-going clinical trials on Astragalus only. There are four on going clinical studies in China in the first half of 2022. Most of the trials were specially for the treatment of fatigue resulted by chemotherapy in the past. In 2022, there’s some new applications.
▶Treating Menstrual Disorders
▶Treatment for diabetic kidney disease
▶For Peripheral Neuropathy.
Details of the four on-going clinical trials on Astragalus in China in 2022.
1. A clinical study aim to evaluate the Efficacy, Safety and Response Predictors of Adjuvant Astragalus Therapy for Diabetic Kidney Disease (READY)
This add-on open-label randomized controlled pragmatic trial is planned to
✅Analyze the effect of add-on astragalus treatment on type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria.
✅Estimate treatment effect, variance, recruitment rate, attrition rate, and change in clinical manifestation including Chinese medicine syndrome for parameters optimization and feasibility assessment for a subsequent phase III randomized controlled trial.
✅Evaluate response predictors for efficacy and safety among type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria receiving add-on astragalus treatment.
The treatment for the phase 2 study is Drug Astragalus powder for the Diabetic Nephropathies and Diabetic Kidney Disease. The update might be later this year as the estimated completion date of the study is on Dec 31, 2022, and this Hongkong-based study started on July 1, 2018.
2. A clinical study on Astragalus included formula for Fatigue Reduction in Cancer Fatigue Induced by Chemotherapy (TCM)
This phase 2 study aim to assess the efficacy and safety of Chinese herbal compound in improving fatigue symptoms and quality of life in cancer patients with chemotherapy. The clinical trial is a Multicenter, Randomized, Double-blind Clinical Trial, the treatment is Drug TCM Formula(including Astragalus roots) for cancer-related problem. The estimated primary completion date is Jan 1,2023 and is started on Sep 15,2021.
3.The clinical trial on prescription Yi Qi Wen Jing is purposed to assess the Preventive Efficacy of the prescription for Oxaliplatin-induced Peripheral Neuropathy
This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial of Yi Qi Wen Jing prescriptions for Preventing Oxaliplatin-induced Peripheral Neuropathy Colorectal Cancer.
The treatment of this phase III study is Minetic granules of Yi Qi Wen Jing prescriptions, which the Astragalus is the main ingredients.
The study start January 1,2021 and is estimated to reach the primary completion on July 1,2022, we believe the update will come soon.
4. The Clinical and Basic Researches Related to Zhen Qi Bu Xue Oral Liquid in Treating Menstrual Disorders.
This clinical study applied treatment Zhen Qi Bu Xue Oral Liquid for adult women menstrual disorders. The ingredients of Zhen Qi Bu Xue Koufuye as follows: sheep placenta, pearl, red ginseng, wolfberry, astragalus, angelica, coix seed, ginger and jujube and the excipients are protein sugar and sodium benzoate.
Beside the Zhen Qi Bu Xue Oral Liquid, this national multicenter prospective, randomized, controlled trial also applied drug Progesterone Capsules and Zhen Qi Bu Xue Oral Liquid plus Progesterone Capsules in the treatment. In consequence, the study has three arm.
✅ One-third of participants will receive Zhen Qi Bu Xue Oral Liquid.
✅ One-third of participants will receive Progesterone Capsules.
✅The rest third will receive Zhen Qi Bu Xue Oral Liquid and Progesterone Capsules in combination.
This clinical study started on Mar 15, 2022, and is estimated to complete the primary on Dec30,2022.
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