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Efficacy and Safety of Kleeb Bua Daeng Formula in Mild Cognitive Impairment Patients: A Phase I Randomized, Double-blind, Placebo-controlled Trial

Efficacy and Safety of Kleeb Bua Daeng Formula in Mild Cognitive Impairment Patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220209007
Enrollment
40
Registered
2022-02-09
Start date
2020-08-21
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Mild cognitive impairment memory function thai traditional herbal medicine kleeb bua daeng

Interventions

two capsules twice a day,two capsules twice a day
Experimental Drug,Placebo Comparator Drug
Kleeb Bua Daeng capsule,Placebo

Sponsors

Chao Phya Abhaibhubejhr Hospital Foundation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: MCI patients in Chao Phya Abhaibhubejhr hospital, Prachinburi of Thailand, were enrolled. The inclusion criteria were as follows: Provision of signed informed consent before any study-specific procedure, MoCA (Montreal Cognitive Assesssment)-T score between 19-24, and 40-70 years of age.

Exclusion criteria

Exclusion criteria: The exclusion criteria were as follows: GFR by Cockcroft formulation less than 40 ml/min, serum alanine aminotransferase and aspartate aminotransferase higher than 2.5 of standard level, patients who receive warfarin, pregnancy or breastfeeding, need for or an anticipated need for oral with any of the following: (a) Cholinesterase inhibitors (b) N-methyl D-aspartate antagonist (NMDA) (c) Cholinesterase inhibitors plus NMDA, and participation in another clinical study with an investigational product at any time during the 30 days before randomization.

Design outcomes

Primary

MeasureTime frame
AST at 3 month ast level,ALT at 3 month alt level,MoCA at 3 month MoCA score,eGFR at 3 month eGFR level

Secondary

MeasureTime frame
adverse event at 3 month number of event

Countries

Thailand

Contacts

Public ContactNatdanai Musigavong

Khon Kaen university

mus_natda@kkumail.com037211088

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026