Ayurvedic Herbal Cleanse Intervention
The Chopra Center’s 6-day Perfect Health program features the signature Zrii Purify™ cleansing system, which is an oral cleanse product that simulates a traditional Ayurvedic panchakarma cleanse. The Ayurvedic Herbal Cleanse Intervention (AHCI) is designed to study the health benefits of the Purify cleanse, which consists of plant-based fiber and oil, as well as Ayurvedic herbs that help to mobilize and eliminate toxins from the body, strengthen digestion, balance metabolism, and improve energy and vitality.
While our previous studies have taken a systems biology approach by incorporating the Zrii Purify™ cleanse with other aspects of the Perfect Health program such as massage, Ayurvedic diet, yoga, and meditation, the Ayurvedic Herbal Cleanse Intervention (AHCI) study will be looking solely at the effects of the Zrii Purify™ cleanse on the gastrointestinal system in addition to overall wellbeing. Participants incorporating the Zrii Purify™ cleanse into their diet will be compared to those participants who are not ingesting the Zrii Purify™ cleanse.
It has long been recognized that ancient practices such as herbal cleansing can promote health, longevity and wellbeing but there is little scientific evidence for this.
We are conducting this study to examine this issue.
Experimental & Control Groups
Professor Paul J. Mills and other scientists and clinicians at the University of California, San Diego (UCSD), the Sanford-Burnham Medical Research Institute (SBMRI) and The Chopra Center for Wellbeing are conducting a research study to find out more about individuals who are taking the Zrii Purify™ herbal cleanse at the Chopra Center for Wellbeing located at Omni La Costa Resort and Spa, in Carlsbad CA. This Ayurvedic Herbal Cleanse Intervention (AHCI) research study will examine the effects of the Zrii Purify™ herbal cleanse product on the functioning of the gastrointestinal system as well as on overall wellbeing as compared to individuals who are not taking the cleanse product.
You may qualify to participate in this study if you are between the ages of 23-65 years, English-speaking, in good health, and plan to use the Zrii Purify™ herbal cleanse product.
There will be approximately 30 participants in this study.
If you chose to participate in this AHCI research study, you will be randomly assigned (like a flip of a coin) to either take the Zrii Purify™ herbal cleanse product as you had planned, or postpone taking the Zrii Purify™ herbal cleanse for approximately 2 weeks and continue with your normal diet.
If you are assigned to the Zrii Purify™ group or to the control group, you will follow the same lifestyle plan, including any dietary guidelines, the only difference will be taking the Zrii Purify™ product if you are assigned to the Zrii group.
Following the study, if you were assigned to the control group, you can then take the Zrii Purify™ herbal cleanse product as you had originally planned.
What will happen to you in this study and which procedures are standard of care and which are experimental?
If you agree to be in this study, the following will happen to you during the study: You will attend and complete 2 in-person laboratory assessments at the Chopra Center for Wellbeing located at Omni La Costa Resort and Spa in Carlsbad, CA during the week that you take the herbal cleanse. Participation will consist in attending a study orientation and laboratory assessment at the beginning of your cleanse and another laboratory assessment approximately one week later at the end of your cleanse. The research activities for each laboratory assessment visit are detailed below.
Beginning of Herbal Cleanse In-Person Laboratory Assessment
- Baseline Case Report Form: You will be asked to respond to questions regarding your health history and status (e.g., current symptoms, medication and vitamin use, health behaviors) and questionnaires regarding your well-being, mood, stress, thinking style, gratitude, and spirituality. You will have the option to complete these questionnaires with paper and pencil or online.
- Vital Signs and Measurements: A research assistant will measure your seated blood pressure, height, weight, waist and hip circumference. These measurements will each be taken twice to ensure accuracy.
- Fasting Blood Draw: You will be asked to fast overnight or at least 8 hours prior to your beginning of stay in-person laboratory assessment session. Your blood will be drawn from a vein in your arm or hand by a licensed phlebotomist before 10:00AM to decrease discomfort from fasting. 10ml of blood (<1 tablespoon) will be drawn.
- Gut Microbiome Sample: You will be provided with a stool sampling kit and small plastic collection containers to collect your own fecal samples one day prior to beginning the cleanse or study date.
End of Stay In-Person Laboratory Assessment
- End of Stay Questionnaires: You will again complete the same questionnaires on well-being, mood, stress, thinking style, gratitude, and spirituality. You will have the option to complete these questionnaires with paper and pencil or online.
- Vital Signs and Measurements: A research assistant will measure your seated blood pressure. These measurements will each be taken twice to ensure accuracy.
- Fasting Blood Draw: You will be asked to fast overnight or at least 8 hours prior to your end of stay in-person laboratory assessment session. Your blood will be drawn from a vein in your arm or hand by a licensed phlebotomist before 10:00AM to decrease discomfort from fasting. 10ml of blood (<1 tablespoon) will be drawn.
- Gut Microbiome Sample: You will be provided with a stool sampling kit and small plastic collection containers to collect your own fecal samples on day 7 (upon completion of the final day) of the cleanse or end study date.
Participant Restrictions During Your Weeklong Herbal Cleanse:
During the study, we ask that you NOT do any of the following activities due to the impact they may have on the sensitive measures we are studying:
- Do NOT engage in any more exercise than you would during your normal lifestyle.
- We encourage participants to refrain from drinking any alcohol during the study. Recreational drug use is prohibited during the study.
- Do NOT eat any food or drink besides water, 8 hours before both of your assessments (e.g. If your appointment is at 6:00AM, you should not eat or drink after 10:00PM the night before).
How much time will each study procedure take, what is your total time commitment, and how long will the study last?
The total time for study participation, which includes the pre- and post-laboratory assessments, is approximately 4 hours. Additionally, you will adhere to your cleanse or study protocol for a total of 7 days. If you are assigned to the cleanse group, you will consume the kit components in the morning and evening, which takes about 15 minutes. Beginning of Cleanse/Mock In-Person Laboratory Assessment: approximately 90 minutes Baseline Case Report Form and questionnaires: approximately 60 minute Vital Signs & Measurements: approximately 10 minutes Fasting Blood Draw: approximately 5 minutes Provide Gut Microbiome Sample: approximately 10 minutes End In-Person Laboratory Assessment: Same measures as pre-visit assessment Your total time for study participation spans 7 days and totals about 4-5 active hours.
A: Those interested in taking the Zrii Purify™ cleanse product AND participating in ground-breaking research, who also qualify to the following criteria: must be between 23-65 years of age, who are employees of the Chopra Center. They must also have not ingested any antibiotics within the past year. Eligible participants, once having completed the eligibility form, will follow the Zrii Purify™ cleanse guidelines. Please review the Study Description for information regarding study requirements and assessments. The eligibility form will be provided to you via email once you have emailed Lizzy Weiss, Chopra Foundation Research Associate, with the subject line: AHCI-Eligibility Form to email@example.com
A: In order to participate you must fit the eligibility criteria. If you feel you qualify after having reviewed the main points above (see question 1), please email Lizzy Weiss, Chopra Foundation Research Associate, with the subject line: AHCI- Eligibility Form to firstname.lastname@example.org. From here, Lizzy will be able to send you an eligibility form to ensure you fit the remainder of the inclusion/exclusion criteria for this study. If you do not qualify, and would like to support the study, we encourage you to find “SBTI” on the donation page of www.choprafoundation.org. All funds directed to SBTI are in efforts to help finance research initiatives the Chopra Center and Chopra Foundation endorse to bring scientific evidence to ancient wisdom and teachings.
A: Participation in the Initiative for Cancer-Survivorship Approached Naturally study requires certain responsibilities such as:
- physiological assessments,
- blood draws,
- psychological questionnaires
among other assessments that may be conducted. You will NOT be paid for your participation, but the Purify™ cleanse product will be funded for you should you be eligible to participate. Please keep in mind there is a time commitment which includes but is not limited to: the study assessments and questionnaires before, during, and after the study, which may take additional time.
A: The Ayurvedic Herbal Cleanse Intervention study will take place on TBD, 2016 at the Omni La Costa Resort and Spa in Carlsbad, CA.
A: No, there is no cost to participate in this study. The Zrii Purify™ cleanse product will be funded for you by the Chopra Foundation, independent fundraising campaigns and donors/sponsors. The only direct cost to you is the time commitment involved as described in Question 3.
A: Please contact Lizzy Weiss, Chopra Foundation Research Associate, with the subject line: FAQ for further inquiries. Emails can be sent to email@example.com.
Main Eligibility Criteria
- Must be between 23-65 years of age.
- Must be a Chopra Center Employee.
- Must be willing to comply with dietary changes.
- Must be relatively healthy.
- Must NOT be taking any recreational drugs.
- Must be available for in-person assessments (blood draws, stool sample, questionnaires, etc.)