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Ayurvedic Herbal Cleanse Intervention (AHCI)

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.
 

Why is this study being done?

It has long been thought 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.
 

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.
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  • 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.
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  • 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.
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  • 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.
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  • 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.
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  • 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:

  1. Do NOT engage in any more exercise than you would during your normal lifestyle.
  2. We encourage participants to refrain from drinking any alcohol during the study. Recreational drug use is prohibited during the study.
  3. 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.

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