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

NCT04869865 | Unknown

• 1 other identifier: AYURCLN-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

mental health; skin health; gut health

Outcome Measures

Primary Outcomes (2)

• Microbiota diversity

  Evaluation of gut microbiome diversity

  3 weeks

• Microbiome intestinal markers

  Zonulin, calprotectin, antibodies against LPS

  3 weeks

Secondary Outcomes (16)

• Serum hemoglobin A1c (HbA1c) levels

  3 weeks

• Serum high-sensitivity C-reactive protein (hsCRP) level

  3 weeks

• Serum triglyceride (TG) level

  3 weeks

• Serum low density lipoprotein (LDL) level

  3 weeks

• Serum high density lipoprotein (HDL) level

  3 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Detoxification cleanse

Dietary Supplement: 9-day detoxification cleanse and 1 week of pre-cleanse transition

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• AyurPrana LLC: collaborator
• Pearl Banyan, LLC: collaborator

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 96815, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Raja Sivamani, MD, MS, AP

CONTACT

916-524-1216; raja.sivamani@integrativeskinresearch.com

Mincy Chakkalakal, BS

CONTACT

279-204-7338; mincy@integrativeskinresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will be given the intervention

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 3, 2021
• Study Start: April 29, 2021
• Primary Completion: April 3, 2022
• Study Completion: April 3, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)