China Amyotrophic Lateral Sclerosis Registry of Patients With Traditional Chinese Medicine

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDongzhimen Hospital, Beijing

About this trial

A multi-center registration study of clinical characteristics of amyotrophic lateral sclerosis (ALS) patients with traditional Chinese medicine (TCM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who refuse informed consent.

Trial population

Patients who meet the criteria will be enrolled from multi-centers in China.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: Amyotrophic lateral sclerosis patients

Trial outcomes

Primary outcomes

1

Effective Survival

The time from disease onset to death, tracheostomy, or permanent assisted ventilation

Time frame
Through study completion, an average of 3 months

Secondary outcomes

1

Overall Survival

Death owing to any causes

Time frame
Through study completion, an average of 3 months
2

Rate of Disease Progression

(48-total ALSFRS-R)/symptom duration (months)

Time frame
Through study completion, an average of 3 months
3

Rate of Forced Vital Capacity (FVC) Decline

The slope of decline of forced vital capacity (FVC) to assess the respiratory function.

Time frame
through study completion, an average of 3 months
4

Rate of Body Mass Index (BMI) Decline

The slope of decline of body mass index (BMI) to assess the disease progression.

Time frame
Through study completion, an average of 3 months

Other outcomes

Sponsors and contacts

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