HealthyNCT04869865
The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health
A study testing 9-day detoxification cleanse and 1 week of pre-cleanse transition in people with Healthy, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
This pilot study will evaluate the effects of a Springtime Home Cleanse on skin, gut, metabolic, and mental health. The study will also assess changes in overall quality of life. The results will be used to design a larger cleanse-based study in the future. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 9-day detoxification cleanse and 1 week of pre-cleanse transition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2021to 3 Apr 2022
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females (ages 18-69)
- Individuals must be able to read and comprehend study procedures and consent forms.
- Individuals who have baseline metabolic, gut or stress dysfunction
- Individuals must be able to minimize activity during the home cleanse for full participation and compliance.
- Individuals must be willing to reduce caffeine, sugar, alcohol, dairy and carbohydrate rich foods throughout the study.
- Individuals must be willing to have flash photo facial images taken with imaging systems.
Who cannot join
- Individuals with a known allergy to lime or lime juice, ginger or ginger pickle, turbinado sugar, rock salt, curcumin, coriander, fennel, cardamom, cinnamon, trikatu, yellow mung dal, kitchari spice, triphala, dashamula and guduchi powder, castor oil and chyavanprash.
- Individuals who are lactose intolerant, or with a known allergy to ghee.
- Individuals who are in the process of being vaccinated.
- Individual who have a history of gastrointestinal inflammatory diseases or a history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis) or other similar systemic diseases in the opinion of the investigator.
- Individuals who are recovering from a serious illness (requiring hospitalization), infection (requiring hospitalization), or surgery within one month of starting the study or unwilling to wait one month after their illness, infection, or surgery prior to starting the study.
- Individuals who are recovering from a non-serious illness or infection who are recovered and unwilling to wait 2 weeks from their illness or infection.
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- Individuals who are in a concurrent intervention based clinical research study at this site or any other facility in the past two weeks.
- Has a condition or is on a medication the investigator and/or designee believes could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results.
- Individuals who have had exposure to systemic antibiotics within the month prior or unwilling to wash out for a month.
- Women who are pregnant or breastfeeding.
- Individuals who are cognitively impaired.
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 96815
Raja Sivamani, MD, MS, AP, 916-524-1216, raja.sivamani@integrativeskinresearch.com
About this study
This pilot study will evaluate the effects of a Springtime Home Cleanse on skin, gut, metabolic, and mental health. The study will also assess changes in overall quality of life. The results will be used to design a larger cleanse-based study in the future.
Read the detailed description
Short-term dietary cleanses and other popular detoxification methods are thought to eliminate accumulated toxins from the body and subsequently, promote health and well-being. Although previous studies have reported improvements in weight loss, blood pressure and insulin resistance with these practices, there is not enough scientific evidence to corroborate these claims. Therefore, the objective of this pilot study is to determine the effects of a short-term dietary cleanse on various parameters of skin, gut, metabolic and mental health and evaluate the aforementioned health claims.
- Conditions
- Healthy
- Being tested
- 9-day detoxification cleanse and 1 week of pre-cleanse transition
- Keywords
- mental health, skin health, gut health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-day detoxification cleanse and 1 week of pre-cleanse transitionDietary supplement
Subjects will participate in the full 9-day Springtime Home Cleanse, including the week prior to a pre-cleanse transition period. The cleanse includes a transition week, 9 days of a monodiet, internal oleation with ghee, external oleation, herbs, purgation, and an enema. During this time, subjects will also attend daily online meetings on Facebook Live throughout the cleanse and on AyurPrana's AyurLearn online portal to participate in guided mediation and yoga. Subjects will also use these platforms to access daily cleanse instructions and journaling topics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Detoxification cleanse Receives: Dietary Supplement: 9-day detoxification cleanse and 1 week of pre-cleanse transition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota diversity
Evaluation of gut microbiome diversity
Measured: 3 weeks
Microbiome intestinal markers
Zonulin, calprotectin, antibodies against LPS
Measured: 3 weeks
Secondary outcomes (16)
Serum hemoglobin A1c (HbA1c) levels
Evaluate serum HbA1c level via ZRT Laboratories Cardiometabolic Panel
Measured: 3 weeks
Serum high-sensitivity C-reactive protein (hsCRP) level
Evaluate serum hsCRP level via ZRT Laboratories Cardiometabolic Panel
Measured: 3 weeks
Serum triglyceride (TG) level
Evaluate serum TG level via ZRT Laboratories Cardiometabolic Panel
Measured: 3 weeks
Serum low density lipoprotein (LDL) level
Evaluate serum LDL level via ZRT Laboratories Cardiometabolic Panel
Measured: 3 weeks
Serum high density lipoprotein (HDL) level
Evaluate serum HDL level via ZRT Laboratories Cardiometabolic Panel
Measured: 3 weeks
Serum very low density lipoprotein (VLDL) level
Evaluate serum VLDL level via ZRT Laboratories Cardiometabolic Panel
Measured: 3 weeks
Salivary diurnal cortisol pattern
Salivary diurnal cortisol pattern via ZRT Laboratories Saliva Hormone Test
Measured: 3 weeks
Facial redness - image based
BTBP Clarity Mini 3D camera
Measured: 3 weeks
Facial wrinkles - image based
BTBP Clarity Mini 3D camera
Measured: 3 weeks
Facial trans-epidermal water loss (TEWL)
Vapometer, Delfin Technologies
Measured: 3 weeks
Tongue changes - image based
Evaluate changes in tongue coating, discoloration, depressions, indentations, and cracking via iPad imaging
Measured: 3 weeks
Quality of Life Survey Based Assessment
Self assessment using World Health Organization (WHO) Quality of Life Questionnaire
Measured: 3 weeks
Safety assessments for GI distress
Self assessment using Digestive Questionnaire
Measured: 3 weeks
Blood pressure
Measured: 3 weeks
Heart Rate
Measured: 3 weeks
Respiratory Rate
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start29 Apr 2021 (estimated)
- Primary completion3 Apr 2022 (estimated)
- Study completion3 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will be given the intervention
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AyurPrana LLC, Pearl Banyan, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869865
- Sponsor's protocol ID
- AYURCLN-01
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health
- ClinicalTrials.gov ID
- NCT04869865
- Acronym / sponsor ID
- AYURCLN-01
- Conditions
- Healthy
- Keywords
- mental health, skin health, gut health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- AyurPrana LLC, Pearl Banyan, LLC
- Study start
- 29 Apr 2021 (estimated)
- Primary completion
- 3 Apr 2022 (estimated)
- Study completion
- 3 Apr 2022 (estimated)
- First posted
- 3 May 2021 (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 pilot study will evaluate the effects of a Springtime Home Cleanse on skin, gut, metabolic, and mental health. The study will also assess changes in overall quality of life. The results will be used to design a larger cleanse-based study in the future.
Detailed description
Short-term dietary cleanses and other popular detoxification methods are thought to eliminate accumulated toxins from the body and subsequently, promote health and well-being. Although previous studies have reported improvements in weight loss, blood pressure and insulin resistance with these practices, there is not enough scientific evidence to corroborate these claims. Therefore, the objective of this pilot study is to determine the effects of a short-term dietary cleanse on various parameters of skin, gut, metabolic and mental health and evaluate the aforementioned health claims.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will be given the intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: 9-day detoxification cleanse and 1 week of pre-cleanse transitionDetoxification cleanse |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females (ages 18-69)
- Individuals must be able to read and comprehend study procedures and consent forms.
- Individuals who have baseline metabolic, gut or stress dysfunction
- Individuals must be able to minimize activity during the home cleanse for full participation and compliance.
- Individuals must be willing to reduce caffeine, sugar, alcohol, dairy and carbohydrate rich foods throughout the study.
Key exclusion criteria (12 listed)
- Individuals with a known allergy to lime or lime juice, ginger or ginger pickle, turbinado sugar, rock salt, curcumin, coriander, fennel, cardamom, cinnamon, trikatu, yellow mung dal, kitchari spice, triphala, dashamula and guduchi powder, castor oil and chyavanprash.
- Individuals who are lactose intolerant, or with a known allergy to ghee.
- Individuals who are in the process of being vaccinated.
- Individual who have a history of gastrointestinal inflammatory diseases or a history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis) or other similar systemic diseases in the opinion of the investigator.
- Individuals who are recovering from a serious illness (requiring hospitalization), infection (requiring hospitalization), or surgery within one month of starting the study or unwilling to wait one month after their illness, infection, or surgery prior to starting the 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 |
|---|---|---|
| 9-day detoxification cleanse and 1 week of pre-cleanse transitionSubjects will participate in the full 9-day Springtime Home Cleanse, including the week prior to a pre-cleanse transition period. The cleanse includes a transition week, 9 days of a monodiet, internal oleation with ghee, external oleation, herbs, purgation, and an enema. During this time, subjects will also attend daily online meetings on Facebook Live throughout the cleanse and on AyurPrana's AyurLearn online portal to participate in guided mediation and yoga. Subjects will also use these platforms to access daily cleanse instructions and journaling topics. | Dietary supplement | Intervention |
Primary outcome
Microbiota diversity
Time frame: 3 weeks
Evaluation of gut microbiome diversity
Microbiome intestinal markers
Time frame: 3 weeks
Zonulin, calprotectin, antibodies against LPS
16 secondary outcomes
Serum hemoglobin A1c (HbA1c) levels
Time frame: 3 weeks
Serum high-sensitivity C-reactive protein (hsCRP) level
Time frame: 3 weeks
Serum triglyceride (TG) level
Time frame: 3 weeks
Serum low density lipoprotein (LDL) level
Time frame: 3 weeks
Serum high density lipoprotein (HDL) level
Time frame: 3 weeks
Serum very low density lipoprotein (VLDL) level
Time frame: 3 weeks
Salivary diurnal cortisol pattern
Time frame: 3 weeks
Facial redness - image based
Time frame: 3 weeks
Facial wrinkles - image based
Time frame: 3 weeks
Facial trans-epidermal water loss (TEWL)
Time frame: 3 weeks
Tongue changes - image based
Time frame: 3 weeks
Quality of Life Survey Based Assessment
Time frame: 3 weeks
Safety assessments for GI distress
Time frame: 3 weeks
Blood pressure
Time frame: 3 weeks
Heart Rate
Time frame: 3 weeks
Respiratory Rate
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 9-day detoxification cleanse and 1 week of pre-cleanse transition in people with Healthy, run by Integrative Skin Science and Research 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 3 May 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja Sivamani, MD, MS, AP (916-524-1216, raja.sivamani@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota diversity (time frame: 3 weeks). 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?
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 3 May 2021.