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

Integrative Skin Science and Research logo

Integrative Skin Science and Research

Status

Unknown

Conditions

Healthy

Treatments

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

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT04869865
AYURCLN-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Intervention
Experimental group
Description:
Detoxification cleanse
Treatment:
Dietary Supplement: 9-day detoxification cleanse and 1 week of pre-cleanse transition

Trial contacts and locations

1

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Central trial contact

Mincy Chakkalakal, BS; Raja Sivamani, MD, MS, AP

Data sourced from clinicaltrials.gov

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