The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health

NCT ID: NCT04869865

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-29

Study Completion Date

2022-04-03

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects will be given the intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Detoxification cleanse

Group Type EXPERIMENTAL

9-day detoxification cleanse and 1 week of pre-cleanse transition

Intervention Type DIETARY_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.

Interventions

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9-day detoxification cleanse and 1 week of pre-cleanse transition

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AyurPrana LLC

UNKNOWN

Sponsor Role collaborator

Pearl Banyan, LLC

UNKNOWN

Sponsor Role collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Integrative Skin Science and Research

Sacramento, California, United States

Site Status

Countries

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United States

Central Contacts

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Raja Sivamani, MD, MS, AP

Role: CONTACT

916-524-1216

Mincy Chakkalakal, BS

Role: CONTACT

279-204-7338

Facility Contacts

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Raja Sivamani, MD, MS, AP

Role: primary

916-524-1216

Other Identifiers

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AYURCLN-01

Identifier Type: -

Identifier Source: org_study_id

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