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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04869865
Other study ID # AYURCLN-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 29, 2021
Est. completion date April 3, 2022

Study information

Verified date April 2021
Source Integrative Skin Science and Research
Contact Raja Sivamani, MD, MS, AP
Phone 916-524-1216
Email raja.sivamani@integrativeskinresearch.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 18
Est. completion date April 3, 2022
Est. primary completion date April 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 69 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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.

Locations

Country Name City State
United States Integrative Skin Science and Research Sacramento California

Sponsors (3)

Lead Sponsor Collaborator
Integrative Skin Science and Research AyurPrana LLC, Pearl Banyan, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microbiota diversity Evaluation of gut microbiome diversity 3 weeks
Primary Microbiome intestinal markers Zonulin, calprotectin, antibodies against LPS 3 weeks
Secondary Serum hemoglobin A1c (HbA1c) levels Evaluate serum HbA1c level via ZRT Laboratories Cardiometabolic Panel 3 weeks
Secondary Serum high-sensitivity C-reactive protein (hsCRP) level Evaluate serum hsCRP level via ZRT Laboratories Cardiometabolic Panel 3 weeks
Secondary Serum triglyceride (TG) level Evaluate serum TG level via ZRT Laboratories Cardiometabolic Panel 3 weeks
Secondary Serum low density lipoprotein (LDL) level Evaluate serum LDL level via ZRT Laboratories Cardiometabolic Panel 3 weeks
Secondary Serum high density lipoprotein (HDL) level Evaluate serum HDL level via ZRT Laboratories Cardiometabolic Panel 3 weeks
Secondary Serum very low density lipoprotein (VLDL) level Evaluate serum VLDL level via ZRT Laboratories Cardiometabolic Panel 3 weeks
Secondary Salivary diurnal cortisol pattern Salivary diurnal cortisol pattern via ZRT Laboratories Saliva Hormone Test 3 weeks
Secondary Facial redness - image based BTBP Clarity Mini 3D camera 3 weeks
Secondary Facial wrinkles - image based BTBP Clarity Mini 3D camera 3 weeks
Secondary Facial trans-epidermal water loss (TEWL) Vapometer, Delfin Technologies 3 weeks
Secondary Tongue changes - image based Evaluate changes in tongue coating, discoloration, depressions, indentations, and cracking via iPad imaging 3 weeks
Secondary Quality of Life Survey Based Assessment Self assessment using World Health Organization (WHO) Quality of Life Questionnaire 3 weeks
Secondary Safety assessments for GI distress Self assessment using Digestive Questionnaire 3 weeks
Secondary Blood pressure 3 weeks
Secondary Heart Rate 3 weeks
Secondary Respiratory Rate 3 weeks
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