BronchiectasisPhase 4NCT03147443
Evaluating the Effects of Traditional Chinese Medicine by N-of-1 Trials
A Phase 4 study testing Individualized Decoction and Tested drug minus heat-clearing herbs in people with Bronchiectasis and Quality of Life, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bronchiectasis, Quality of Life, Traditional Chinese Medicine
- What is being tested?
- Individualized Decoction and Tested drug minus heat-clearing herbs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437
Haiyin Huang, M.D., 008602165161782, haiyin_huang@126.com
Haiyin Huang, M.D.
About this study
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"
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.
Read the 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.
- Conditions
- Bronchiectasis, Quality of Life, Traditional Chinese Medicine, Sputum, Symptoms, Individuality
- Being tested
- Individualized Decoction, placebo, Tested drug minus heat-clearing herbs
- Keywords
- traditional Chinese medicine, Drugs, Chinese Herbal, N-of-1 trials, sputum, symptoms, individualized treatment, stable bronchiectasis
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized DecoctionDrug
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.
placeboDrug
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.
Tested drug minus heat-clearing herbsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Individualized Decoction; Drug: Tested drug minus heat-clearing herbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
24 h Sputum Volume
We measured the 24h sputum volume at the beginning and the end of each treatment period of the trial. To ensure the accuracy of the measurement, we asked the patients to spit sputum into a collector with scales from 8:00 am to the next 8:00 am. We used the mean value of the sputum volume for 3 consecutive days as the outcome.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Mar 2017
- Primary completion1 Nov 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haiyinhuang, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147443
- Sponsor's protocol ID
- haiyinhuang
- Status last verified
- May 2017
- First submitted
- 3 May 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25477988Lee 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.
PubMed 23101012Zi 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.
PubMed 35087595
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03147443
- Acronym / sponsor ID
- haiyinhuang
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individualized Decoction | Experimental | Drug: Individualized Decoction, Drug: placeboIt 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. |
| placebo | Placebo comparator | Drug: Individualized Decoction, Drug: placeboPlacebo 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. |
| Tested drug minus heat-clearing herbs | Active comparator | Drug: Individualized Decoction, Drug: Tested drug minus heat-clearing herbsIt 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized DecoctionApplied 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. | Drug | Individualized Decoction, Tested drug minus heat-clearing herbs, placebo |
| placeboApplied 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. | Drug | Individualized Decoction, placebo |
| Tested drug minus heat-clearing herbsIt 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. | Drug | Tested drug minus heat-clearing herbs |
Primary outcome
Patient Self-Rated Symptom Score
Time frame: 4 weeks
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.
1 secondary outcome
24 h Sputum Volume
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Background: PubMed 25477988Huang 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.
- Background: PubMed 23101012Lee 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.
- Derived from this study: PubMed 35087595Zi 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.
- Individual participant dataSharing planned: No
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Individualized Decoction and Tested drug minus heat-clearing herbs in people with Bronchiectasis and Quality of Life, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiyin Huang, M.D. (008602165161782, haiyin_huang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Self-Rated Symptom Score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03147443, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.