Rice SerumNCT06475222
Facial Serum and Mask and Ready-to-drink Jelly From Thai Rice
A study testing Study 1: Facial serum with alpha albutin, Study 1: Facial serum with Tubtim Chumpae rice extract and Study 2: Facial mask with Hom Pathum rice extract in people with Rice Serum and Rice Mask, run by Burapha University at 1 site in Thailand.
Trial summary
This study consisted of three sub-studies including 1) development and evaluation of facial serum from Thai rice on skin moisture, elasticity, oiliness, and melanin in healthy participants 2) development and evaluation of facial mask from Thai rice on skin moisture, elasticity, oiliness, and melanin in healthy… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rice Serum, Rice Mask, Rice Jelly
- What is being tested?
- Study 1: Facial serum with alpha albutin, Study 1: Facial serum with Tubtim Chumpae rice extract and Study 2: Facial mask with Hom Pathum rice extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Age between 18 to 50 years
- Healthy
- Interested in facial serum with Thai rice extract or facial mask with Thai rice extract or jelly from with Thai rice
Who cannot join
- History of adverse effects from facial serum or mask application or jelly consumption
- Skin allergy
- Skin disorders
- Skin wounds
- History of allergy to Thai rice, particularly in Tubtim Chumpae and Hom Pathum
- History of allergy to facial serum or mask, i.e., serum or mask from rice
Show all 13Show fewer
- History of allergy to gelatin
- Signs or symptoms of fever or infection
- Abnormal body mass index
- Regular smokers or alcohol drinkers (>2 times per week)
- Regular exerciser (>2 times per week or >150 min per week)
- Regular intake of dietary supplements, i.e., vitamins, antioxidants
- Hypertension, diabetes, cardiovascular disease, respiratory disease, endocrine disease, neuromuscular disease, musculoskeletal disease, liver disease, renal disease, immune disease, infectious disease, or cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Effectiveness Evaluation of Facial Serum and Mask and Ready-to-drink Jelly From Thai Rice (Oryza Sativa L.)
This study consisted of three sub-studies including 1) development and evaluation of facial serum from Thai rice on skin moisture, elasticity, oiliness, and melanin in healthy participants 2) development and evaluation of facial mask from Thai rice on skin moisture, elasticity, oiliness, and melanin in healthy participants and 3) development and evaluation of ready-to-drink jelly from Thai rice on controlling blood glucose and endurance time in healthy participants.
Read the detailed description
Study 1: 30 male and female participants, age 30-50 years will be randomly applied with facial serum producing from either 2% alpha albutin (standard facial serum) or Tubtim Chumphae rice extract on either right side or left side of their face daily for 12 weeks.
Study 2: 60 male and female participants, age 30-50 years will be randomly assigned into 2 groups including 1) control group (n = 30): participants will not receive any facial mask for 12 weeks and 2) treatment group (n = 30): participants will be applied with home-based program facial mask with Hom Pathum rice extract for 30 min/day, 2 days/week for 12 weeks.
Study 3: this study consists of 2 sub-studies. Study 3.1: 25 male and female participants, age 18-35 years will be randomly consumed with control jelly, jelly with Tubtim Chumphae rice, and jelly with Hom Pathum rice at 3.5 g/kg body weight. All participants will be measured for blood glucose levels before consumption and after consumption at 30, 60, 90, and 120 min. Study 3.2: 25 male and female participants, age 18-35 years will be randomly consumed with control jelly, jelly with Tubtim Chumphae rice, and jelly with Hom Pathum rice at 3.5 g/kg body weight. After each consumption, all participants will perform walking or running on treadmill at intensity of 80% maximal heart rate to measure maximal oxygen consumption.
- Conditions
- Rice Serum, Rice Mask, Rice Jelly
- Being tested
- Study 1: Facial serum with alpha albutin, Study 1: Facial serum with Tubtim Chumpae rice extract, Study 2: Facial mask with Hom Pathum rice extract, Study 3: Control jelly, Study 3: Jelly with Tubtim Chumpae rice
- Keywords
- Thai rice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study 1: Facial serum with alpha albutinOther
Applying with facial serum with 2% alpha albutin as active comparator daily for 12 weeks.
Study 1: Facial serum with Tubtim Chumpae rice extractOther
Applying with facial serum with Tubtim Chumpae rice extract as experimental intervention daily for 12 weeks.
Study 2: Facial mask with Hom Pathum rice extractOther
Applying with facial mask with Hom Pathum rice extract as experimental intervention for 30 min/day, 2 days/week for 12 weeks.
Study 3: Control jellyOther
Consumption with control jelly as active comparator at 3.5 g/kg body weight.
Study 3: Jelly with Tubtim Chumpae riceOther
Consumption with jelly with Tubtim Chumpae rice as experimental intervention at 3.5 g/kg body weight.
Study 3: Jelly with Hom Pathum riceOther
Consumption with jelly with Hom Pathum rice as experimental intervention at 3.5 g/kg body weight.
| Study group | Role | What they receive |
|---|---|---|
| Study 1: Facial serum with alpha albutin | Active comparator | Participants will be randomly applied with home-based program of facial serum producing from 2% alpha albutin (standard facial serum) on either right side or left side of their face daily for 12 weeks. Receives: Other: Study 1: Facial serum with alpha albutin |
| Study 1: Facial serum with Tubtim Chumpae rice extract | Experimental | Participants will be randomly applied with home-based program of facial serum producing from Tubtim Chumpae rice extract on either right side or left side of their face daily for 12 weeks. Receives: Other: Study 1: Facial serum with Tubtim Chumpae rice extract |
| Study 2: Facial mask with Hom Pathum rice extract | Experimental | Participants will receive home-based program of facial mask with Hom Pathum rice extract for 30 min/day, 2 days/week for 12 weeks. Receives: Other: Study 2: Facial mask with Hom Pathum rice extract |
| Study 3: Control jelly | Active comparator | Participants will consume with control jelly at 3.5 g/kg body weight. Consumption will be taken at Burapha University. Receives: Other: Study 3: Control jelly |
| Study 3: Jelly with Tubtim Chumpae rice | Experimental | Participants will consume with Tubtim Chumpae rice jelly at 3.5 g/kg body weight. Consumption will be taken at Burapha University. Receives: Other: Study 3: Jelly with Tubtim Chumpae rice |
| Study 3: Jelly with Hom Pathum rice | Experimental | Participants will consume with Hom Pathum rice jelly at 3.5 g/kg body weight. Consumption will be taken at Burapha University. Receives: Other: Study 3: Jelly with Hom Pathum rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of skin moisture
Studies 1 and 2 determine level of skin moisture in arbitrary unit (no unit) using Multiprobe Adapter System with Corneometer® CM 825 probe.
Measured: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Level of skin elasticity
Studies 1 and 2 determine level of skin elasticity in arbitrary unit (no unit) using Multiprobe Adapter System with Cutometer® 580 probe.
Measured: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Level of skin oiliness
Studies 1 and 2 determine level of skin oiliness in arbitrary unit (no unit) using Multiprobe Adapter System with Sebumeter® SM 815 probe.
Measured: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Level of skin melanin
Studies 1 and 2 determine level of skin melanin in arbitrary unit (no unit) using Multiprobe Adapter System with Mexameter® MX18 probe.
Measured: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Level of blood glucose
Study 3.1 determines level of blood glucose in mg/dL unit
Measured: Before jelly consumption and after jelly consumption at 30, 60, 90, and 120 minutes
Level of maximal oxygen consumption
Study 3.2 determines level of maximal oxygen consumption in mL/kg/min unit by walking or running on treadmill at intensity of 80% maximal heart rate.
Measured: After jelly consumption for 30 minutes
Concentration of interferon-gamma
Study 3.2 determines concentration of interferon-gamma in serum in pg (picogram)/mL unit
Measured: Before and immediately after maximal oxygen consumption test
Concentration of tumor necrosis factor-alpha
Study 3.2 determines concentration of tumor necrosis factor-alpha in serum in pg (picogram)/mL unit
Measured: Before and immediately after maximal oxygen consumption test
Concentration of interleukin-10
Study 3.2 determines concentration of interleukin-10 in serum in pg (picogram)/mL unit
Measured: Before and immediately after maximal oxygen consumption test
Level of superoxide dismutase activity
Study 3.2 determines level of superoxide dismutase activity in percentage (%) unit
Measured: Before and immediately after maximal oxygen consumption test
Concentration of malondialdehyde
Study 3.2 determines concentration of malondialdehyde in micromolar (uM) unit
Measured: Before and immediately after maximal oxygen consumption test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Sep 2024
- Primary completion30 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rice SerumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Study 1 is single group model, study 2 is parallel model, and study 3 is crossover model.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burapha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piyapong Prasertsri, Burapha University
- Investigators
- Piyapong Prasertsri, Ph.D., Principal investigator, Burapha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475222
- Sponsor's protocol ID
- IRB1-047/2567
- Status last verified
- Feb 2025
- First submitted
- 20 Jun 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Effectiveness Evaluation of Facial Serum and Mask and Ready-to-drink Jelly From Thai Rice (Oryza Sativa L.)
- ClinicalTrials.gov ID
- NCT06475222
- Acronym / sponsor ID
- IRB1-047/2567
- Conditions
- Rice Serum, Rice Mask, Rice Jelly
- Keywords
- Thai rice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Burapha UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study consisted of three sub-studies including 1) development and evaluation of facial serum from Thai rice on skin moisture, elasticity, oiliness, and melanin in healthy participants 2) development and evaluation of facial mask from Thai rice on skin moisture, elasticity, oiliness, and melanin in healthy participants and 3) development and evaluation of ready-to-drink jelly from Thai rice on controlling blood glucose and endurance time in healthy participants.
Detailed description
Study 1: 30 male and female participants, age 30-50 years will be randomly applied with facial serum producing from either 2% alpha albutin (standard facial serum) or Tubtim Chumphae rice extract on either right side or left side of their face daily for 12 weeks.
Study 2: 60 male and female participants, age 30-50 years will be randomly assigned into 2 groups including 1) control group (n = 30): participants will not receive any facial mask for 12 weeks and 2) treatment group (n = 30): participants will be applied with home-based program facial mask with Hom Pathum rice extract for 30 min/day, 2 days/week for 12 weeks.
Study 3: this study consists of 2 sub-studies. Study 3.1: 25 male and female participants, age 18-35 years will be randomly consumed with control jelly, jelly with Tubtim Chumphae rice, and jelly with Hom Pathum rice at 3.5 g/kg body weight. All participants will be measured for blood glucose levels before consumption and after consumption at 30, 60, 90, and 120 min. Study 3.2: 25 male and female participants, age 18-35 years will be randomly consumed with control jelly, jelly with Tubtim Chumphae rice, and jelly with Hom Pathum rice at 3.5 g/kg body weight. After each consumption, all participants will perform walking or running on treadmill at intensity of 80% maximal heart rate to measure maximal oxygen consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Study 1 is single group model, study 2 is parallel model, and study 3 is crossover model.
| Arm | Type | Receives |
|---|---|---|
| Study 1: Facial serum with alpha albutin | Active comparator | Other: Study 1: Facial serum with alpha albutinParticipants will be randomly applied with home-based program of facial serum producing from 2% alpha albutin (standard facial serum) on either right side or left side of their face daily for 12 weeks. |
| Study 1: Facial serum with Tubtim Chumpae rice extract | Experimental | Other: Study 1: Facial serum with Tubtim Chumpae rice extractParticipants will be randomly applied with home-based program of facial serum producing from Tubtim Chumpae rice extract on either right side or left side of their face daily for 12 weeks. |
| Study 2: Facial mask with Hom Pathum rice extract | Experimental | Other: Study 2: Facial mask with Hom Pathum rice extractParticipants will receive home-based program of facial mask with Hom Pathum rice extract for 30 min/day, 2 days/week for 12 weeks. |
| Study 3: Control jelly | Active comparator | Other: Study 3: Control jellyParticipants will consume with control jelly at 3.5 g/kg body weight. Consumption will be taken at Burapha University. |
| Study 3: Jelly with Tubtim Chumpae rice | Experimental | Other: Study 3: Jelly with Tubtim Chumpae riceParticipants will consume with Tubtim Chumpae rice jelly at 3.5 g/kg body weight. Consumption will be taken at Burapha University. |
| Study 3: Jelly with Hom Pathum rice | Experimental | Other: Study 3: Jelly with Hom Pathum riceParticipants will consume with Hom Pathum rice jelly at 3.5 g/kg body weight. Consumption will be taken at Burapha University. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female
- Age between 18 to 50 years
- Healthy
- Interested in facial serum with Thai rice extract or facial mask with Thai rice extract or jelly from with Thai rice
Key exclusion criteria (13 listed)
- History of adverse effects from facial serum or mask application or jelly consumption
- Skin allergy
- Skin disorders
- Skin wounds
- History of allergy to Thai rice, particularly in Tubtim Chumpae and Hom Pathum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study 1: Facial serum with alpha albutinApplying with facial serum with 2% alpha albutin as active comparator daily for 12 weeks. | Other | Study 1: Facial serum with alpha albutin |
| Study 1: Facial serum with Tubtim Chumpae rice extractApplying with facial serum with Tubtim Chumpae rice extract as experimental intervention daily for 12 weeks. | Other | Study 1: Facial serum with Tubtim Chumpae rice extract |
| Study 2: Facial mask with Hom Pathum rice extractApplying with facial mask with Hom Pathum rice extract as experimental intervention for 30 min/day, 2 days/week for 12 weeks. | Other | Study 2: Facial mask with Hom Pathum rice extract |
| Study 3: Control jellyConsumption with control jelly as active comparator at 3.5 g/kg body weight. | Other | Study 3: Control jelly |
| Study 3: Jelly with Tubtim Chumpae riceConsumption with jelly with Tubtim Chumpae rice as experimental intervention at 3.5 g/kg body weight. | Other | Study 3: Jelly with Tubtim Chumpae rice |
| Study 3: Jelly with Hom Pathum riceConsumption with jelly with Hom Pathum rice as experimental intervention at 3.5 g/kg body weight. | Other | Study 3: Jelly with Hom Pathum rice |
Primary outcome
Level of skin moisture
Time frame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Studies 1 and 2 determine level of skin moisture in arbitrary unit (no unit) using Multiprobe Adapter System with Corneometer® CM 825 probe.
Level of skin elasticity
Time frame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Studies 1 and 2 determine level of skin elasticity in arbitrary unit (no unit) using Multiprobe Adapter System with Cutometer® 580 probe.
Level of skin oiliness
Time frame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Studies 1 and 2 determine level of skin oiliness in arbitrary unit (no unit) using Multiprobe Adapter System with Sebumeter® SM 815 probe.
Level of skin melanin
Time frame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]
Studies 1 and 2 determine level of skin melanin in arbitrary unit (no unit) using Multiprobe Adapter System with Mexameter® MX18 probe.
Level of blood glucose
Time frame: Before jelly consumption and after jelly consumption at 30, 60, 90, and 120 minutes
Study 3.1 determines level of blood glucose in mg/dL unit
Level of maximal oxygen consumption
Time frame: After jelly consumption for 30 minutes
Study 3.2 determines level of maximal oxygen consumption in mL/kg/min unit by walking or running on treadmill at intensity of 80% maximal heart rate.
Concentration of interferon-gamma
Time frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines concentration of interferon-gamma in serum in pg (picogram)/mL unit
Concentration of tumor necrosis factor-alpha
Time frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines concentration of tumor necrosis factor-alpha in serum in pg (picogram)/mL unit
Concentration of interleukin-10
Time frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines concentration of interleukin-10 in serum in pg (picogram)/mL unit
Level of superoxide dismutase activity
Time frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines level of superoxide dismutase activity in percentage (%) unit
Concentration of malondialdehyde
Time frame: Before and immediately after maximal oxygen consumption test
Study 3.2 determines concentration of malondialdehyde in micromolar (uM) unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piyapong Prasertsri, Ph.D. principal investigator
Burapha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study 1: Facial serum with alpha albutin, Study 1: Facial serum with Tubtim Chumpae rice extract and Study 2: Facial mask with Hom Pathum rice extract in people with Rice Serum and Rice Mask, run by Burapha University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of skin moisture (time frame: Before intervention, immediately after intervention, ends of week 4, week 8, and week 12]). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.