Amyotrophic Lateral SclerosisCARE-TCMNCT04885374
China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine
An observational study of Amyotrophic Lateral Sclerosis, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Mar 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the criteria will be enrolled from multi-centers in China.
Who may be able to join
- Patients aged 18 years and older.
- Patients with possible, laboratory supported probable, probable, or definite ALS according to the revised El Escorial criteria.
- ALS patients treated with traditional Chinese medicine.
Who cannot join
- Patients who refuse informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, 100700
Ying Gao, MD, PhD, +86-10-84013209, gaoying973@126.com
About this study
A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).
Read the detailed description
The CARE-TCM is a prospective, multi-center, patient registry study. Eligible ALS patients with TCM treatments will be enrolled in the registry. After enrollment, this research collects the individual characteristics of patients' status. Longitudinal follow-up data are collected from both patients (primary caregivers) and their treating neurologists every 3 months for 5 years. The aims of the CARE-TCM are to: 1) explore the general characteristics of ALS patients with TCM and; 2) assess the effectiveness and safety of various TCMs on ALS based on nationwide registry outcome collecting process.
- Conditions
- Amyotrophic Lateral Sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Amyotrophic lateral sclerosis patients | Amyotrophic lateral sclerosis patients with traditional Chinese medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Survival
The time from disease onset to death, tracheostomy, or permanent assisted ventilation
Measured: Through study completion, an average of 3 months
Secondary outcomes (4)
Overall Survival
Death owing to any causes
Measured: Through study completion, an average of 3 months
Rate of Disease Progression
(48-total ALSFRS-R)/symptom duration (months)
Measured: Through study completion, an average of 3 months
Rate of Forced Vital Capacity (FVC) Decline
The slope of decline of forced vital capacity (FVC) to assess the respiratory function.
Measured: through study completion, an average of 3 months
Rate of Body Mass Index (BMI) Decline
The slope of decline of body mass index (BMI) to assess the disease progression.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Mar 2021
- Primary completion1 May 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, MD, PhD, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885374
- Sponsor's protocol ID
- ALS-2021-CARE-TCM
- Acronym
- CARE-TCM
- Status last verified
- May 2021
- First submitted
- 8 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jia Q, Song Y, Zhang C, Li M, Feng L, Sugimoto K, Zhang X, Liu J, Gao Y. Reasons and experience for patients with amyotrophic lateral sclerosis using traditional Chinese medicine: a CARE-TCM based mixed method study. BMC Complement Med Ther. 2024 Jun 12;24(1):231. doi: 10.1186/s12906-024-04513-2.
PubMed 38867220Song Y, Li M, Sugimoto K, Han Y, Liu J, Ma B, Song H, Zhang C, Gao Y; CARE-TCM Group. China amyotrophic lateral sclerosis registry of patients with Traditional Chinese Medicine (CARE-TCM): Rationale and design. J Ethnopharmacol. 2022 Feb 10;284:114774. doi: 10.1016/j.jep.2021.114774. Epub 2021 Oct 23.
PubMed 34699945
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT04885374
- Acronym / sponsor ID
- CARE-TCM / ALS-2021-CARE-TCM
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 13 May 2021 (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.
A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).
Detailed description
The CARE-TCM is a prospective, multi-center, patient registry study. Eligible ALS patients with TCM treatments will be enrolled in the registry. After enrollment, this research collects the individual characteristics of patients' status. Longitudinal follow-up data are collected from both patients (primary caregivers) and their treating neurologists every 3 months for 5 years. The aims of the CARE-TCM are to: 1) explore the general characteristics of ALS patients with TCM and; 2) assess the effectiveness and safety of various TCMs on ALS based on nationwide registry outcome collecting process.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amyotrophic lateral sclerosis patients | – | –Amyotrophic lateral sclerosis patients with traditional Chinese medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the criteria will be enrolled from multi-centers in China.
Key inclusion criteria (3 listed)
- Patients aged 18 years and older.
- Patients with possible, laboratory supported probable, probable, or definite ALS according to the revised El Escorial criteria.
- ALS patients treated with traditional Chinese medicine.
Key exclusion criteria (1 listed)
- Patients who refuse informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effective Survival
Time frame: Through study completion, an average of 3 months
The time from disease onset to death, tracheostomy, or permanent assisted ventilation
4 secondary outcomes
Overall Survival
Time frame: Through study completion, an average of 3 months
Rate of Disease Progression
Time frame: Through study completion, an average of 3 months
Rate of Forced Vital Capacity (FVC) Decline
Time frame: through study completion, an average of 3 months
Rate of Body Mass Index (BMI) Decline
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Derived from this study: PubMed 38867220Jia Q, Song Y, Zhang C, Li M, Feng L, Sugimoto K, Zhang X, Liu J, Gao Y. Reasons and experience for patients with amyotrophic lateral sclerosis using traditional Chinese medicine: a CARE-TCM based mixed method study. BMC Complement Med Ther. 2024 Jun 12;24(1):231. doi: 10.1186/s12906-024-04513-2.
- Derived from this study: PubMed 34699945Song Y, Li M, Sugimoto K, Han Y, Liu J, Ma B, Song H, Zhang C, Gao Y; CARE-TCM Group. China amyotrophic lateral sclerosis registry of patients with Traditional Chinese Medicine (CARE-TCM): Rationale and design. J Ethnopharmacol. 2022 Feb 10;284:114774. doi: 10.1016/j.jep.2021.114774. Epub 2021 Oct 23.
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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.
Ying Gao, MD, PhD principal investigator
Dongzhimen Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Dongzhimen Hospital, Beijing 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 May 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Gao, MD, PhD (+86-10-84013209, gaoying973@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Survival (time frame: Through study completion, an average of 3 months). 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 NCT04885374, which also lists 2 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 13 May 2021.