Sebum ProductionNCT03477825
Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin
A study testing Rubia Cordifolia and Triphala in people with Sebum Production and Stool Microbiome, run by University of California, Davis at 1 site in United States.
Trial summary
Few studies have assessed the effects of Triphala and Rubia Cordifolia from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sebum Production, Stool Microbiome, Transepidermal Water Loss
- What is being tested?
- Rubia Cordifolia and Triphala
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2018to 25 Jan 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 60 years of age
- Subject must be able to read and comprehend study procedures and consent forms.
Who cannot join
- Subject should be generally healthy and have no smoking history in the past one year.
- Subjects must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.
- Those who are unable to discontinue topical medications for two weeks.
- Those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study.
- Those who are unable to discontinue their Triphala and Rubia Cordifolia regimen for one month prior to starting study.
- Subjects who are postmenopausal
Show all 9Show fewer
- Those who are pregnant or breastfeeding
- Those that are prisoners or cognitively impaired
- Those who have a known allergy to Rubia cordifolia, Emblica officinalis, Terminalia bellerica, Terminalia chebula.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis, Department of Dermatology
Sacramento, California, 95816
About this study
Official title: Pilot Study on the Effects of Oral Triphala and Rubia Cordifolia on the Gut Microbiome and Skin Biophysical Properties
Few studies have assessed the effects of Triphala and Rubia Cordifolia from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.
Read the detailed description
Herbal supplements such as Rubia cordifolia and Triphala [a mix of Emblica officinalis (Amalaki), Terminalia bellerica (Bibhitaki), and Terminalia chebula (Haritaki)] are commonly used for skin based treatments in India. However, the scientific evidence for their specific effects on the skin are scant. Rubia cordifolia is a root that is used in skin care for pigmentation and inflammation.1 Triphala is thought to have antioxidant properties and reduce inflammation in general. Herbs have been shown to modulate the gut microbiome, as previous studies have suggested that triphala may modify the gut microbiome.2
However, few studies have assessed the effects of these herbs from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.
- Conditions
- Sebum Production, Stool Microbiome, Transepidermal Water Loss, Facial Brrightness, Erythema, Wrinkles
- Being tested
- Placebo Oral Tablet, Rubia Cordifolia, Triphala
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral TabletDietary supplement
Group A: Placebo group (n = 10)
- Supplement appearing similar to Herbal formulations
- Each placebo tablet will contain microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating.
- Dose: subjects in this group will take 4 placebo tablets per day
Rubia CordifoliaDietary supplement
Also called Manjistha
Group B: R. cordifolia group (n = 10)
- 2,000 mg R. cordifolia per day - supplied by Banyan Botanicals and following standard supplementation doses on commercially available supplement (https://www.banyanbotanicals.com/manjistha-tablets/)
- Each tablet contains 500 mg of R. cordifolia per tablet.
TriphalaDietary supplement
Group C: Triphala group (n= 10)
- Tablets of Triphala will be supplied from Banyan Botanicals (https://www.banyanbotanicals.com/triphala-tablets-11/)
- Each tablet contains mix Emblica officinalis, Terminalia bellerica, and Terminalia chebula
- Dose: subjects will take 4 tablets per day, with a total dose of 2,000 mg of total herb.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Group A: Placebo group (n = 10)
* Supplement appearing similar to Herbal formulations
* Each placebo tablet will contain microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating.
* Dose: subjects in this group will take 4 placebo tablets per day Receives: Dietary Supplement: Placebo Oral Tablet |
| Rubia Cordifolia | Experimental | Group B: R. cordifolia group (n = 10)
* 2,000 mg R. cordifolia per day - supplied by Banyan Botanicals and following standard supplementation doses on commercially available supplement (https://www.banyanbotanicals.com/manjistha-tablets/)
* Each tablet contains 500 mg of R. cordifolia per tablet. Receives: Dietary Supplement: Rubia Cordifolia |
| Triphala | Experimental | Group C: Triphala group (n= 10)
* Tablets of Triphala will be supplied from Banyan Botanicals (https://www.banyanbotanicals.com/triphala-tablets-11/)
* Each tablet contains mix Emblica officinalis, Terminalia bellerica, and Terminalia chebula
* Dose: subjects will take 4 tablets per day, with a total dose of 2,000 mg of total herb. Receives: Dietary Supplement: Triphala |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sebum excretion rate
Sebum production measured by sebumeter
Measured: 4 weeks +/- 1 week
Stool microbiome diversity via stool sample
Stool microbiome diversity via stool sample
Measured: 4 weeks +/- 1 week
Secondary outcomes (8)
Transepidermal water loss via Tewameter
Transepidermal water loss via Tewameter
Measured: 4 weeks +/- 1 week
Facial brightness measured via photographic assessment
Facial brightness measured via photographic assessment
Measured: 4 weeks +/- 1 week
Facial redness via photographic assessment
Facial redness via photographic assessment
Measured: 4 weeks +/- 1 week
Facial wrinkles via photographic assessment
Facial wrinkles via photographic assessment
Measured: 4 weeks +/- 1 week
Facial shine via photographic assessment
Facial shine via photographic assessment
Measured: 4 weeks +/- 1 week
Digestion Questionnaire
We will assess digestive symptoms such as stooling patterns and regularity based on level of frequency (Never, Sometimes, Always, Unsure).
Measured: 4 weeks +/- 1 week
Symptoms Questionnaire
We will assess general health related symptoms based on level of frequency (Never, Sometimes, Often, Unsure).
Measured: 4 weeks +/- 1 week
Food Intake Log
We ask for a food diary that will account for all food and drink intake in a given day for three days prior to their next visit. The diary will note what food/beverage and how much of that item was consumed.
Measured: 4 weeks +/- 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start12 Mar 2018
- Primary completion16 Aug 2018
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sebum ProductionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty (30) subjects meeting the inclusion criteria without any of the exclusion criteria will be enrolled in this study. This study will be a double blinded study. Each subject will be randomized a priori to receive either placebo, Rubia cordifolia, or Triphala tablets.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477825
- Sponsor's protocol ID
- 1174110
- Status last verified
- May 2019
- First submitted
- 13 Mar 2018
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual patient data.
Publications
Peterson CT, Pourang A, Dhaliwal S, Kohn JN, Uchitel S, Singh H, Mills PJ, Peterson SN, Sivamani RK. Modulatory Effects of Triphala and Manjistha Dietary Supplementation on Human Gut Microbiota: A Double-Blind, Randomized, Placebo-Controlled Pilot Study. J Altern Complement Med. 2020 Nov;26(11):1015-1024. doi: 10.1089/acm.2020.0148. Epub 2020 Sep 18.
PubMed 32955913
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of Oral Triphala and Rubia Cordifolia on the Gut Microbiome and Skin Biophysical Properties
- ClinicalTrials.gov ID
- NCT03477825
- Acronym / sponsor ID
- 1174110
- Conditions
- Sebum Production, Stool Microbiome, Transepidermal Water Loss, Facial Brrightness, Erythema, Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 26 Mar 2018 (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.
Few studies have assessed the effects of Triphala and Rubia Cordifolia from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.
Detailed description
Herbal supplements such as Rubia cordifolia and Triphala [a mix of Emblica officinalis (Amalaki), Terminalia bellerica (Bibhitaki), and Terminalia chebula (Haritaki)] are commonly used for skin based treatments in India. However, the scientific evidence for their specific effects on the skin are scant. Rubia cordifolia is a root that is used in skin care for pigmentation and inflammation.1 Triphala is thought to have antioxidant properties and reduce inflammation in general. Herbs have been shown to modulate the gut microbiome, as previous studies have suggested that triphala may modify the gut microbiome.2
However, few studies have assessed the effects of these herbs from a skin biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's barrier properties and the gut microbiome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Thirty (30) subjects meeting the inclusion criteria without any of the exclusion criteria will be enrolled in this study. This study will be a double blinded study. Each subject will be randomized a priori to receive either placebo, Rubia cordifolia, or Triphala tablets.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo Oral TabletGroup A: Placebo group (n = 10) * Supplement appearing similar to Herbal formulations * Each placebo tablet will contain microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating. * Dose: subjects in this group will take 4 placebo tablets per day |
| Rubia Cordifolia | Experimental | Dietary Supplement: Rubia CordifoliaGroup B: R. cordifolia group (n = 10) * 2,000 mg R. cordifolia per day - supplied by Banyan Botanicals and following standard supplementation doses on commercially available supplement (https://www.banyanbotanicals.com/manjistha-tablets/) * Each tablet contains 500 mg of R. cordifolia per tablet. |
| Triphala | Experimental | Dietary Supplement: TriphalaGroup C: Triphala group (n= 10) * Tablets of Triphala will be supplied from Banyan Botanicals (https://www.banyanbotanicals.com/triphala-tablets-11/) * Each tablet contains mix Emblica officinalis, Terminalia bellerica, and Terminalia chebula * Dose: subjects will take 4 tablets per day, with a total dose of 2,000 mg of total herb. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 to 60 years of age
- Subject must be able to read and comprehend study procedures and consent forms.
Key exclusion criteria (9 listed)
- Subject should be generally healthy and have no smoking history in the past one year.
- Subjects must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.
- Those who are unable to discontinue topical medications for two weeks.
- Those who are unable to discontinue systemic antibiotics or oral probiotics for one month prior starting the study.
- Those who are unable to discontinue their Triphala and Rubia Cordifolia regimen for one month prior to starting study.
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 |
|---|---|---|
| Placebo Oral TabletGroup A: Placebo group (n = 10) * Supplement appearing similar to Herbal formulations * Each placebo tablet will contain microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating. * Dose: subjects in this group will take 4 placebo tablets per day | Dietary supplement | Placebo |
| Rubia CordifoliaAlso: ManjisthaGroup B: R. cordifolia group (n = 10) * 2,000 mg R. cordifolia per day - supplied by Banyan Botanicals and following standard supplementation doses on commercially available supplement (https://www.banyanbotanicals.com/manjistha-tablets/) * Each tablet contains 500 mg of R. cordifolia per tablet. | Dietary supplement | Rubia Cordifolia |
| TriphalaGroup C: Triphala group (n= 10) * Tablets of Triphala will be supplied from Banyan Botanicals (https://www.banyanbotanicals.com/triphala-tablets-11/) * Each tablet contains mix Emblica officinalis, Terminalia bellerica, and Terminalia chebula * Dose: subjects will take 4 tablets per day, with a total dose of 2,000 mg of total herb. | Dietary supplement | Triphala |
Primary outcome
Sebum excretion rate
Time frame: 4 weeks +/- 1 week
Sebum production measured by sebumeter
Stool microbiome diversity via stool sample
Time frame: 4 weeks +/- 1 week
Stool microbiome diversity via stool sample
8 secondary outcomes
Transepidermal water loss via Tewameter
Time frame: 4 weeks +/- 1 week
Facial brightness measured via photographic assessment
Time frame: 4 weeks +/- 1 week
Facial redness via photographic assessment
Time frame: 4 weeks +/- 1 week
Facial wrinkles via photographic assessment
Time frame: 4 weeks +/- 1 week
Facial shine via photographic assessment
Time frame: 4 weeks +/- 1 week
Digestion Questionnaire
Time frame: 4 weeks +/- 1 week
Symptoms Questionnaire
Time frame: 4 weeks +/- 1 week
Food Intake Log
Time frame: 4 weeks +/- 1 week
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 15 May 2019.
- Derived from this study: PubMed 32955913Peterson CT, Pourang A, Dhaliwal S, Kohn JN, Uchitel S, Singh H, Mills PJ, Peterson SN, Sivamani RK. Modulatory Effects of Triphala and Manjistha Dietary Supplementation on Human Gut Microbiota: A Double-Blind, Randomized, Placebo-Controlled Pilot Study. J Altern Complement Med. 2020 Nov;26(11):1015-1024. doi: 10.1089/acm.2020.0148. Epub 2020 Sep 18.
- Individual participant dataSharing planned: No. We do not plan to share individual patient data.
Related trials for Sebum Production
Active, not recruiting
Evaluation of the Scalp Skin Care Effects of Premium Revitalizing Elixir and Topical 5% Minoxidil
Scalp Health, Alopecia
Recruiting
Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris
Acne Vulgaris
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.
Raja Sivamani, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubia Cordifolia and Triphala in people with Sebum Production and Stool Microbiome, run by University of California, Davis at 1 site in United States.
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 2 inclusion and 9 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 15 May 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Sebum excretion rate (time frame: 4 weeks +/- 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03477825, which also lists 1 linked publication.
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 15 May 2019.