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Efficacy of DA-9701 treatment to improve gastrointestinal symptoms

Efficacy of DA-9701 treatment to improve gastrointestinal symptoms and related quality of life in POTS: single-center, crossover, randomized, double-blind, placebo-controlled, pilot study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0006932
Enrollment
24
Registered
2022-01-17
Start date
2022-04-22
Completion date
Unknown
Last updated
2024-11-14

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

Conditions

None listed

Interventions

Drug : Each arm will be allocated 1:1 ratio by ranomization, Placebo/DA-9701 will be descripted for 8weeks. Wash out period is 4weeks. After finishing wash-out period each subject will be changed Plac

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. age : 18-65 2. Postural Orthostatic Tachycardia Syndrome 3. Not intake prokinetics((itopride, gasmotin, corydalis tuber, levosulpride,domperidone etc) within 2months 4. Having symptoms like as below Loss of appetite, Retching, abdominal distention, indigestion, early satiety, dysphagia, Foreign body sensation at neck and pharingolaryngeal, Gastroesophageal reflux, nausea/vomitting

Exclusion criteria

Exclusion criteria: 1. Current of previous history of structural heart disease or arrhythmia 2. Current of previous history of Thyroid diseas or Adrenal disease 3. Other systemic conditions including ; infection disease, auto-immune disease, COPD, hepatitis and liver cirrhosis, acute cardiac failure or MI, pernicious anemia,acute respiratory disease etc, 4. Pregnant or breast-feeding subject 5. Subject who has inappropriate medical condition for entry into this study by investigator's judgement. 6. Known prior hypersensitivity to DA-9701 7. Known joining other study of gastorintestinal investigational product within 3months

Design outcomes

Primary

MeasureTime frame
NDI-K (Korean Nepean Dyspepsia Index) Score

Secondary

MeasureTime frame
SF-36 Score

Countries

Korea, Republic of

Contacts

Public ContactDa-Young Seo

Asan Medical Center

seoddyy@naver.com+82-2-3010-8457

Outcome results

None listed

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