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

NCT03147443 | Unknown Phase 4

• 1 other identifier: haiyinhuang
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis; Quality of Life; Traditional Chinese Medicine; Sputum; Symptoms; Individuality

Keywords

traditional Chinese medicine; Drugs, Chinese Herbal; N-of-1 trials; sputum; symptoms; individualized treatment; stable bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Patient Self-Rated Symptom Score

  Patients rated the severity of the symptoms (such as cough, expectoration, shortness of breath, chest pain, and fatigue) on a 7 point visual analogue scales. The higher the score, the more severe the symptom.

  4 weeks

Secondary Outcomes (1)

• 24 h Sputum Volume

  4 weeks

Other Outcomes (1)

• COPD Assessment Test

  4 weeks

Study Arms (3)

Individualized Decoction

EXPERIMENTAL

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.

Drug: Individualized Decoction; Drug: placebo

placebo

PLACEBO COMPARATOR

Placebo is made by dextrin, bitter agent, edible pigment etc and added 5% test drug. The placebo and test drug have no differences in dosage form, appearance, color, specification, label, and so forth. The placebo is taken by one decoction a day and divided into 2 doses, for 3 weeks in each observation period.

Drug: Individualized Decoction; Drug: placebo

Tested drug minus heat-clearing herbs

ACTIVE COMPARATOR

It is the decoction of the Individualized Syndrome Differentiation Decoction(tested drug) minus heat-clearing herbs. For example, heat-clearing herbs such as Scutellaria baicalensis or Herba Violae will be removed from the Syndrome Differentiation Decoction. This control Chinese herbal decoction is taken by one decoction a day and divided into 2 doses, for 3 weeks in each observation period.

Drug: Individualized Decoction; Drug: Tested drug minus heat-clearing herbs

Interventions

Individualized Decoction DRUG

Applied in the Tested Drug Observation Period. 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.

Individualized Decoction; Tested drug minus heat-clearing herbs; placebo

placebo DRUG

Applied in the placebo Observation Period. Placebo is made by dextrin, bitter agent, edible pigment etc and added 5% test drug. The test drug and control drug have no differences in dosage form, appearance, color, specification, label, and so forth.

Individualized Decoction; placebo

Tested drug minus heat-clearing herbs DRUG

It is the decoction of the Syndrome Differentiation Decoction(tested drug) minus heat-clearing herbs. For example, heat-clearing herbs such as Scutellaria baicalensis or Herba Violae will be removed from the Syndrome Differentiation Decoction.

Tested drug minus heat-clearing herbs

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200437, China

RECRUITING

Related Publications (3)

• Huang H, Yang P, Xue J, Tang J, Ding L, Ma Y, Wang J, Guyatt GH, Vanniyasingam T, Zhang Y. Evaluating the Individualized Treatment of Traditional Chinese Medicine: A Pilot Study of N-of-1 Trials. Evid Based Complement Alternat Med. 2014;2014:148730. doi: 10.1155/2014/148730. Epub 2014 Nov 11.

  PMID: 25477988 BACKGROUND

• Lee BY, Lee S, Lee JS, Song JW, Lee SD, Jang SH, Jung KS, Hwang YI, Oh YM. Validity and Reliability of CAT and Dyspnea-12 in Bronchiectasis and Tuberculous Destroyed Lung. Tuberc Respir Dis (Seoul). 2012 Jun;72(6):467-74. doi: 10.4046/trd.2012.72.6.467. Epub 2012 Jun 29.

  PMID: 23101012 BACKGROUND

• Zi S, Huang H, Yang P, Xu M, Wu Y, Wang Z, Ge F, Chen X. Evaluating the Effects of Heat-Clearing Traditional Chinese Medicine in Stable Bronchiectasis by a Series of N-of-1 Trials. Evid Based Complement Alternat Med. 2022 Jan 17;2022:6690638. doi: 10.1155/2022/6690638. eCollection 2022.

  PMID: 35087595 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Central Study Contacts

Haiyin Huang, M.D.

CONTACT

008602165161782; haiyin_huang@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Placebo is made by dextrin, bitter agent, edible pigment etc and added 5% test drug. The test drug and control drug have no differences in dosage form, appearance, color, specification, label, and so forth.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 10, 2017
• Study Start: March 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 31, 2019
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)