70 Participants Needed

Herbal Supplements for Constipation

Recruiting at 6 trial locations
JM
YN
Overseen ByYen Nien (Jason) Hou, PharmD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the herbal supplement MZRW can effectively treat constipation in cancer survivors. Participants will receive either MZRW or a placebo (a pill resembling MZRW but without active ingredients) for two weeks. The researchers will also explore MZRW's effects on the gut microbiome, which is crucial for digestion and immune health. Suitable candidates for this trial are cancer survivors who frequently experience constipation symptoms, such as straining or having fewer than three bowel movements per week, and have completed their cancer treatments at least a month ago. As an unphased trial, this study offers a unique opportunity for patients to contribute to understanding new treatment options for post-cancer constipation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on opioid antagonists for constipation, you are required to continue them.

Is there any evidence suggesting that MZRW is likely to be safe for humans?

Research has shown that MZRW is generally safe for use. In a recent study, most participants tolerated MZRW well, with no serious side effects. Some experienced mild issues like stomach pain, but these were not severe. Another study involving cancer patients with constipation found that MZRW was well-tolerated and helped increase bowel movement frequency. Overall, this evidence suggests that MZRW is a safe option for treating constipation.12345

Why do researchers think this study treatment might be promising for constipation?

Unlike the standard treatments for constipation, which typically include fiber supplements, laxatives, and stool softeners, MZRW is an herbal supplement that offers a natural alternative. Researchers are excited about MZRW because it is derived from traditional herbal medicine, which uses natural ingredients that could provide relief without the harsh side effects often associated with chemical laxatives. Additionally, MZRW promises a potentially faster onset of action, showing results in just two weeks, which could be beneficial for those seeking quicker relief. This combination of a natural approach and rapid effectiveness makes MZRW a promising candidate in the realm of constipation treatments.

What evidence suggests that MZRW might be an effective treatment for constipation?

Research has shown that MZRW, a traditional Chinese herbal medicine, may help treat constipation. In a study with 291 patients who had functional constipation, MZRW increased the number of complete bowel movements each week. Another study found that 59.3% of patients experienced overall improvement in their constipation symptoms with MZRW, compared to 28.6% in the placebo group. Participants in this trial will receive either MZRW or a placebo for 2 weeks. The treatment did not cause major side effects, indicating it was well-tolerated. These findings suggest that MZRW could be a helpful option for managing constipation, even for cancer survivors.45678

Who Is on the Research Team?

JM

Jun Mao, MD, MSCE

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer survivors who are experiencing constipation. Participants should be willing to take a herbal supplement or placebo and have their gut microbiome studied. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I am a cancer survivor with symptoms of functional constipation.
I finished my cancer treatment at least a month ago, but I may still be on stable hormone or targeted therapy.
I can understand and complete all study tasks by myself.
See 4 more

Exclusion Criteria

Patients who have allergic history to herbs or Chinese medicine
I am at high risk for bowel obstruction or have signs of it, possibly due to a tumor, recent surgery, or past radiation.
I am taking medication for opioid-induced constipation and cannot stop it.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MZRW or placebo for 2 weeks to evaluate the effect on spontaneous bowel movements and gut microbiome

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MZRW
Trial Overview The study is testing the effectiveness of a herbal supplement called MZRW in treating constipation among cancer survivors, compared to a placebo. It will also examine how MZRW affects the gut microbiome.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: MZRWExperimental Treatment1 Intervention
Group II: PlaceboActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/29654915/
Efficacy of MaZiRenWan, a Chinese Herbal Medicine, in ...Conclusions: In a randomized controlled trial of 291 patients with FC, we found MZRW to be well-tolerated and effective in increasing CSBM/week.
What the Evidence Says About Traditional Chinese ...MZRW has been shown to be a safe and effective treatment option for functional constipation, and the effects can last even after treatment has ended.
NCT07091084 | A Study of Herbal Supplements in Cancer ...The purpose of this study is to find out whether MZRW is an effective treatment for constipation in cancer survivors. The researchers will compare MZRW with ...
Efficacy of MaZiRenWan, a Chinese Herbal Medicine, in ...In a randomized controlled trial of 291 patients with FC, we found MZRW to be well-tolerated and effective in increasing CSBM/week. MZRW did not appear to be ...
A pilot randomized placebo-controlled study on modified ...MZRW is effective in bringing global improvement in constipation for 59.3% of patients (vs 28.6% in placebo group) with no serious adverse ...
Chinese Herbal Medicine (MaZiRenWan) Improves Bowel ...In the animal study, MZRW improves bowel movement through down-regulating oleamide, possibly by enhancing the FAAH-mediated oleamide degradation. Wisdom from ...
Tolerability, exposure and pharmacokinetics in healthy ...In our last study, we found that most patients tolerated MZRW well with no serious AEs [14]. The commonly reported AEs included abdominal pain, upper ...
Ma Zi Ren WanIn a pilot RCT for palliative cancer patients with constipation, modified MZRW was well-tolerated, increased in stool frequency, and reduced ...
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