Evaluating the Effects of Traditional Chinese Medicine by N-of-1 Trials

Brief Title

Evaluating the Effects of Traditional Chinese Medicine by N-of-1 Trials

Official Title

The Study on the Effects of Traditional Chinese Medicine Through a Series of N-of-1 Trials Based on the Mathematical Model of "Carryover Effect"

Brief Summary

      Treatment based on syndrome differentiation is the essence of traditional Chinese
      Medicine(TCM) and forms the individualized treatment. N-of-1 trials may be a good clinical
      effect evaluation method for the individualized treatment of TCM. This study aims to compare:
      (1) the efficacy of syndrome differentiation(individualized decoction) with placebo, (2)the
      efficacy of syndrome differentiation(individualized decoction) with the same prescription
      minus heat-clearing Chinese herbs, for patients with stable bronchiectasis through N-of-1
      trials.
    

Detailed Description

      Traditional Chinese medicine is one of the important part of complementary and alternative
      medicine in the world, and it plays increasingly important role in the international medical
      practice. Treatment based on syndrome differentiation is the essence of traditional Chinese
      Medicine (TCM) and forms the individualized treatment. However, this individualized TCM
      intervention often makes it difficult for population-based RCTs to carry out a standard form.
      N-of-1 trials may be a good clinical effect evaluation method for the individualized
      treatment of TCM.

      The key hypothesis of this study is that: (1) the efficacy of syndrome
      differentiation(individualized decoction) will be better than placebo in patients with stable
      bronchiectasis through N-of-1 trials. (2) the efficacy of syndrome
      differentiation(individualized decoction) will be better than the same prescription minus
      heat-clearing Chinese herbs in patients with stable bronchiectasis through N-of-1 trials. The
      difference of efficacy may be various according to the individual severity of phlegm-heat.

      In this study, We will conduct a single center N-of-1 trials in 36 patients with stable
      bronchiectasis without hemoptysis and respiratory failure. These N-of-1 trials will be
      randomized, double-blind, crossover comparisons of individualized herbal decoction with
      control decoction within individual patients. Each n-of-1 trial has 3 pairs of treatment
      periods. The duration of each treatment period will be 4 weeks. We will compare :(1) the
      efficacy of syndrome differentiation(individualized decoction) with placebo, (2) the efficacy
      of syndrome differentiation(individualized decoction) with the same prescription minus
      heat-clearing Chinese herbs, in patients with stable bronchiectasis through N-of-1 trials.
      The primary outcome is patient self-reported symptoms(such as cough, expectoration, shortness
      of breath, chest pain, and fatigue) scores on a 7 point visual analogue scale. Secondary
      outcomes are 24-hour sputum volume and CAT（The COPD Assessment Test） scores. We use paired t
      test for single case. Mixed effects model taking account of "Carryover Effects" and
      meta-analysis will be used for a series of N-of-1 trials as a group.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Patient Self-Rated Symptom Score

Secondary Outcome

 24 h Sputum Volume

Condition

Bronchiectasis

Intervention

Individualized Decoction

Study Arms / Comparison Groups

 Individualized Decoction

Description:  It is the highly individualized treatment of traditional Chinese medicine,the modification of Bronchiectasis Stabilization Decoction(Radix Lithospermi 15 g, Rhizoma Fagopyri Cymosi 30 g, Radix Ophiopogonis 15 g, Poria cocos 15 g, Radix Astragali 20 g, Rhizoma Bletillae 10 g, Platycodon grandiflorum 10 g, and Semen Coicis 30 g) based on syndrome differentiation. For example,for patients with qi and yin deficiency syndrome, we added Radix Adenophorae, and Radix Rehmanniae Recens. Besides, the herbs in a prescription could be changed according to different symptoms of individual patients.
The Chinese herbal decoction is taken by one decoction a day and divided into 2 doses, for 3 weeks in each observation period.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

36

Start Date

March 1, 2017

Completion Date

December 31, 2019

Primary Completion Date

November 1, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  the diagnostic criteria based on the consensus of Chinese experts and the guidelines
             for noncystic fibrosis bronchiectasis issued by the British Thoracic Society in 2010;

          -  male or female, aged 18-70 years;

          -  being in the stable stage, and no acute exacerbation of bronchiectasis within the past
             three weeks;

          -  frequency of acute exacerbation of bronchiectasis ≤ 3 times every year;

          -  signed informed consent for participation.

        Exclusion Criteria:

          -  having developed respiratory failure with estimated survival time less than one year;

          -  having hemoptysis as a comorbidity;

          -  having complications by active tuberculosis;

          -  being pregnant or with severe heart, liver,and kidney dysfunctions;

          -  participating in other pharmacological clinical trials within the past 3 months.
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, 008602165161782, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT03147443

Organization ID

haiyinhuang

Responsible Party

Principal Investigator

Study Sponsor

Shanghai University of Traditional Chinese Medicine

Study Sponsor

, , 

Verification Date

May 2017