Chinese Herbal Medicine for Constipation Begins Clinical Trial in US

A new Chinese herbal medicine is heading to the US for a clinical trial to help with constipation relief. Constipation is a common, distressing digestive issue seen in a variety of health conditions. It is characterized by reduced stool frequency, incomplete stool evacuation, straining, and a sense of blockage in anorectal area.

In the United States, constipation accounts for about 1 million hospital visits annually. Standard treatment options such as fiber supplements, laxatives, and stool softeners are not entirely effective and can cause adverse effects. Hence, many people are turning to traditional Chinese medicine for constipation relief (1^✔ ✔Trusted Source
Constipation Treatment: A Review

Go to source).

In such a scenario, a new herbal drug developed in Hong Kong has been authorized to conduct a clinical trial in the US. The Centre for Chinese Herbal Medicine Drug Development (CDD) of Hong Kong Baptist University (HKBU) has developed this new Chinese herbal medicine for treating constipation.

New Chinese Herbal Medicine, CDD-2101, for Constipation

Considering the success of the Investigational New Drug Application sent to the U.S. Food and Drug Administration (FDA), CDD has been approved to conduct a phase I clinical trial of the new drug. The clinical trial will start later this year.

Constipation occurs when the muscles of the large intestine do not properly move the food particles through and out of the colon. Slow movement of food can result in excess absorption of water by the colon, causing hard, dry stools.

In general, normal movements should be soft and easy to pass and should happen daily. However, it is common for people to have painful constipation and pass stools only a few times a week, or have less frequent bowel movement.

The reasons behind the imbalance of water in the colon, or the improper functioning of intestinal muscles can be different. Finding the root cause is very different and people often go for temporary relief.

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Fortunately, traditional Chinese Medicine treatment for constipation comprises traditional herb formulations that have been used for centuries as a natural laxative, which can also strengthen the muscle action of the intestines (2^✔ ✔Trusted Source
Roles of Chinese Medicine and Gut Microbiota in Chronic Constipation

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The formula of MaZiRenWan (MZRW) composed of six Chinese herbs has been commonly used for constipation throughout Asia since 200 A.D. By combining the actions of these herbs, MZRW can moisten the Intestines, drains heat, promotes bowel movement, and unblocks the bowel.

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Although previous studies show that MZRW has purgative and laxative effects and may be useful for constipation, there are significant methodological weaknesses. Being investigated from the first randomized controlled trial (RCT) published in 1983 based on the practitioner's experience, or experts' comments, but not the results from stringent clinical trials, could be misleading.

Milestone of Chinese Medicine in International Standards

This new approval move for clinical trials could give us a better picture of the herbal drug. The main ingredients of the drug to be used in the clinical trial, CDD-2101 contain hemp seed, bitter apricot seed, rhubarb, bran stir-fried immature orange fruit, magnolia bark, and white peony root.

The HKBU research team collaborated with researchers from the University of Chicago and the University of Macau to submit an Investigational New Drug Application for CDD-2101 according to the requirements for botanical drug development of the U.S. FDA. Later they got the authorization to conduct a phase I clinical trial.

HKBU is exceptional in promoting the development of Chinese medicine and conducting cutting-edge scientific research in this area. The University received funding to establish the CDD in 2020, which significantly increased its comprehensive capabilities in the research and development of Chinese medicine (3^✔ ✔Trusted Source
Chinese Herbal Medicine (MaZiRenWan) Improves Bowel Movement in Functional Constipation Through Down-Regulating Oleamide

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The clinical trial in the US will provide them with invaluable experience in conducting clinical trials at Hong Kong’s first Chinese Medicine Hospital in the future.

CDD-2101 is a novel drug developed by combining a traditional Chinese herbal formulation and advanced technologies, the U.S. FDA’s authorization to conduct a clinical trial for this drug is considered an important milestone in the development of Chinese medicine and it once again reflects the dedication to promoting the internationalization of Chinese medicine.

The trial will start later this year using 20 healthy participants. The participants will be asked to take a single dose of CDD-2101 or a placebo under 24-hour surveillance in a research center in the US.

The phase I clinical trial will be followed by a phase II study to collect the safety and efficacy data from constipation patients. A large-scale phase III study will further evaluate the treatment efficacy of CDD-2101 and detects any unforeseeable side effects.

After the completion of phase II and III clinical trials, along with animal studies and human clinical trials, the details of the manufacturing of the drug in a New Drug Application will be submitted to the U.S. FDA for review.

References:

1. Constipation Treatment: A Review - (https://journals.lww.com/orthopaedicnursing/Abstract/2020/05000/Constipation_Treatment__A_Review.13.aspx)
2. Roles of Chinese Medicine and Gut Microbiota in Chronic Constipation - (https://www.hindawi.com/journals/ecam/2019/9372563/)
3. Chinese Herbal Medicine (MaZiRenWan) Improves Bowel Movement in Functional Constipation Through Down-Regulating Oleamide - (https://www.frontiersin.org/articles/10.3389/fphar.2019.01570/full)

Source-Medindia