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Quality control and safety of Prasaprohyai 95%ethanolic extract capsules in healthy volunteer (Clinical Trial phase I)

Quality control and safety of Prasaprohyai 95%ethanolic extract capsules in healthy volunteer (Clinical Trial phase I)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20191008002
Enrollment
24
Registered
2019-10-08
Start date
2017-08-30
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Healthy volunteer Prasaprohyai remedy&#44

Interventions

Plant materials All PSPY component plant materials were bought from various sources. The plant parts were identified by the botanist at the Herbarium of Southern Center of Thai Medicinal Plants at Fac
Prince of Songkhla University&#44
Songkhla province&#44
Thailand The voucher specimen number of each plant material and was homogenously mixed. The mixed powder was macerated with 95% ethanol (2:1) for 3 days&#44
filtered with Whatman number 1 paper. The residue of PSPY was remacerated twice and the same treatment was applied. These three filtrate were combined and the solvent removed using a rotary evaporator
20 °C until use. The extractive yield was 5.05 %w/w. A 100 mg of extract and other ingradients were filled into a capsule size 0 in a capsule blister pack and sealed with aluminum foil. Prasaprohyai
weight variation&#44
loss on drying&#44
heavy metals contamination and disintegration. ,Plant materials All PSPY component plant materials were bought from various sources. The plant parts were identified by the botanist at the Herbarium
filtered with Whatman number 1 paper. The residue of PSPY was remacerated twice and the same treatment was applied. These three filtrate were combined and the solvent removed usi
Active Comparator Drug,Active Comparator Drug
Prasaprohyai extract capsule (100mg),Prasaprohyai extract capsule (200mg)

Sponsors

Faculty of Medicine, Thammasat univercity
Lead Sponsor
Center of excellence in applied Thai Traditional medicine research
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: The criteria for recruitment were; age 20–60 years old, healthy, or without serious medical conditions, and able to follow the instructions for 8 weeks.

Exclusion criteria

Exclusion criteria: The criteria for exclusion were allergic reactions to Prasaprohyai medications, receive other medication, pregnant, lactating women or participate in other studies were excluded from the study.

Design outcomes

Primary

MeasureTime frame
laboratory test Week0, 3, 6, 8 Liver function test, renal function test, CBC, FBS, Cholesterol

Secondary

MeasureTime frame
Side effect Week0, 3,6,8 Record

Countries

Thailand

Contacts

Public ContactWaipoj Chanvimalueng

Faculty of Medicine

waipoj@tu.ac.th029269749

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Feb 7, 2026