An Effectiveness and Safety Study of Chinese Herbal Medicine for Functional Constipation
Condition: Functional Gastrointestinal Disorders; Constipation
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      Functional constipation (FC) is a common complaint in clinical practice, but treatment for
      this condition in conventional medicine is suboptimal. Complementary and alternative
      medicines, especially Chinese herbal medicine (CHM) are used frequently by patients, however,
      there is little research evidence about these commonly used CHM. The purpose of the study is
      evaluate the efficacy and safety of an ancient CHM formula, MaZiRenWan (MZRW), by comparing
      with placebo.
    

Detailed description: 
      Constipation is a common gastrointestinal complaint in clinical practice, which affects in
      estimated 12%-19% of American, 14% of Asian, and up to 27% of the population depending on
      demographic factor, sampling, and definition. With the unsatisfactory response to current
      symptomatic treatments, many patients seek help from traditional Chinese medicine (TCM),
      mostly by taking Chinese herbal medicine (CHM).

      According to the TCM theory, constipation can be broadly divided into two types, excessive
      and deficient, based on the underlying aetiology. The former is characterized by the presence
      of Heat or pathological accumulation of Qi. Heat causes constipation by drying the Intestines
      and the stool. Patients present with hard, dry, pellet like stool, red complexion, dry mouth
      or halitosis, red tongue with a dry yellow coat, and slippery and rapid pulse. Qi stagnation
      causes constipation by disrupting the normal movement and descent of Stomach and Intestinal
      Qi. Patients present difficulty in passing stools, feelings of incomplete evacuation,
      abdominal distension or pain, frequent belching and flatulence, tongue with thin coat and
      wiry pulse. The latter, deficient constipation, is delineated as the dryness from
      insufficient fluid lubrication in the form of blood or lack of propulsion power from the
      deficiency of Qi or Yang. Besides, the treatment approaches vary from syndrome to syndrome.

      The formula of MaZiRenWan (MZRW) composed of six Chinese herbs is firstly recorded in a TCM
      classic, Discussion of Cold-induced Disorders (Shang Han Lun), and it has been commonly used
      for constipation in excessive pattern throughout Asia since the Han Dynasty (A.D. 200). By
      combining the actions of these herbs, MZRW can moisten the Intestines, drain heat, promote
      the movement of Qi and unblock the bowel. Although previous studies show that MZRW has
      purgative and laxative effects and may be useful for functional constipation (FC), there are
      significant methodological weaknesses. Furthermore, the dose of CHM intervention being
      investigated from the first randomized controlled trial (RCT) published in 1983 is always
      based on the practitioner's experience, TCM literatures, or experts' comments, but not the
      results from stringent clinical trials, such as dose determination study. Therefore, the
      evidence produced will be attenuated or even misleading if improper dose is taken.

      In the present study, the efficacy and safety of MZRW in optimal dosage were justified by
      comparing with placebo under strict clinical trial design.
    

Intervention name(s): MaZiRenWan (MZRW); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MZRW granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily; Placebo granule dissolved in 150ml hot water (oral), 7.5g/sachet, twice daily
Other intervention name(s): Hemp Seed Pill; MZRW Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional Constipation; Chinese Herbal Medicine; MaZiRenWan; Hemp Seed Pill; Traditional Chinese Medicine; Herbal Medicine