A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but
      treatment for this condition in conventional medicine is suboptimal. Complementary and
      alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by
      patients with FC, but there is little research evidence about these commonly used CHM. The
      purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the
      optimal dosage.
    

Detailed description: 
      Functional constipation (FC) is a common complaint in clinical practice, with the estimated
      prevalence 14.3% in Hong Kong, as nearly affecting 1 million Hong Kong People in different
      extent. It is comparable with western population, which is 15% in North America. By the
      definition of Rome II criteria, FC comprises a group of functional disorders, which presents
      as persistent difficult, infrequent or seemingly incomplete defecation.

      Constipation is often perceived to be benign, easily treated condition with short-term
      treatment being relatively straightforward. However, the fact is the management of FC is
      perplexed as some subjects complain of constipation more than decade. Moreover, chronic
      constipation can develop into more serious bowel complaints, such as faecal impaction,
      incontinence and bowel perforations. There is also accumulating evidence shown that
      constipated subjects have significantly higher anxiety and depression scores and lower
      quality of life. Therefore, the demand of effective agents to normalize bowel function is
      extremely large.

      Conventional treatment for constipation mainly relies on dietary fibre and laxatives.
      Although there is no credible evidence that any serious problem is associated with their
      prolonged use, the treatment of it has been suboptimal. First, a recent systematic review
      pointed out that there were paucity of trials for many commonly used agents, therefore, their
      use might not be well validated. Second, many patients with severe constipation do not
      respond adequately or lose of effectiveness after a short period of time. Third, many
      patients who intake dietary fibre complain of flatulence, distension, bloating and poor
      taste. As a result, the compliance is low as about 50%. Fourth, the use of osmotic laxatives,
      such as polyethylene glycol, become increasingly popular due to fewer side effects and better
      taste, however, the prices are much more expensive than other medications. Many constipation
      sufferers seek help from alternative medicine, especially from Chinese herbal medicine. For
      example, according to a telephone survey in Hong Kong, more than 85% of constipated subjects
      seek for coping strategies, such as asking for medical consultations, taking prescribed
      medicine and seeking for alternative therapy, involving Chinese medicine.

      Traditional Chinese medicine (TCM) is particularly attractive as their effectiveness in
      treating functional disorders and retaining balance of body functions. The CHM used in study
      is derived from classic text of Chinese medicine (Shang Han Lun, Discussion of Cold-induced
      Disorders), which can "moisten the intestines, drain heat, promote the movement of qi and
      unblock the bowel".

      It is well known that randomized controlled trial (RCT) is the gold standard to test the
      efficacy of intervention, thus in this project, we attempt to follow the basic requirements
      of RCT to testify the efficacy and safety of CHM on FC, as well as to determine the optimal
      dosage. We believe such study will benefit the advancement of CHM, or even as the foundation
      of research study in future.
    

Intervention name(s): MaZiRenWan (MZRW) Low dose; MaZiRenWan (MZRW) Median dose; MaZiRenWan (MZRW) High dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dissolved MaZiRenWan (MZRW) granule (2.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks; Dissolved MaZiRenWan (MZRW) granule (5.0g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks; Dissolved MaZiRenWan (MZRW) granule (7.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
Other intervention name(s): Hemp Seed Pill; Hemp Seed Pill; Hemp Seed Pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Randomized Controlled Trials; Medicine, Chinese Traditional; Medicine, Herbal; Constipation