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A randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of nine-flavor Yang-boosting formula in the treatment of multiple system atrophy and orthostatic hypotension

A randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of nine-flavor Yang-boosting formula in the treatment of multiple system atrophy and orthostatic hypotension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000940
Enrollment
Unknown
Registered
2025-05-09
Start date
2022-05-01
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple system atrophy

Interventions

control group: placebo
treatment group :Nine-flavor Yang-raising formula

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for MSA, including "possible" and "probable" MSA; 2. Meet OH diagnostic criteria; 3. Patients aged 30-80 years old, male and female; 4. Participate in clinical study voluntarily and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Use vasoconstrictor within 2 days before baseline; 2. Persistent and serious hypertension (systolic blood pressure = 180mmHg or diastolic blood pressure = 110mmHg), which cannot be relieved by taking antihypertensive drugs; 3. Neurogenic orthostatic hypotension such as simple autonomic nervous failure, Parkinson's disease, Lewy body dementia, diabetes autonomic nervous disorder; 4. Orthostatic hypotension caused by non-neurogenic reasons such as cardiovascular system disease, adrenal dysfunction, insufficient blood volume; 5. Orthostatic hypotension caused by long-term regular use of tricyclic antidepressants (amitriptyline, etc.), diuretics (hydrochlorothiazide, furosemide, etc.) and prostate drugs (terazosin, tamsulosin, etc.); 6. Arrhythmias, including but not limited to sinus tachycardia (HR = 90 times/min), frequent atrial or ventricular premature beats, atrioventricular block, etc; 7. Those with serious heart, brain, liver, kidney and other system diseases; 8. Those with severe cognitive impairment who cannot cooperate with the examination and treatment.

Design outcomes

Primary

MeasureTime frame
Orthostatic hypotension symptom Checklist;—

Secondary

MeasureTime frame
Clinical symptom Evaluation Scale of vertigo;Balanced Confidence Scale;Unified Multisystem Atrophy Score Scale;Mean blood pressure in standing and lying positions;—

Countries

China

Contacts

Public Contact??

Xiyuan Hospital, China Academy of Chinese Medical Sciences

ningxia20056789@sina.com13521021829

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026