Functional Assessment of Ashwagandaha Root Extract During Weight Loss
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|ClinicalTrials.gov Identifier: NCT03112824|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : November 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stress Reaction Sleep Disturbance Craving Obesity||Drug: Ashwagandha Root Extract Capsule Drug: Placebo Capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||If the PSS score is than 20, those patients who are interested in participating are consented to the Ashwagandha study. The patients will then be randomized in a double-blind fashion to receive a 31 day supply of study capsules which will be either Ashwagandha 300mg twice a day or identical placebo capsules in a 1:1 ratio. They will be given careful directions into the use of the study capsules and will be asked to mark a daily log (See addendum #3: Treatment Log) of taking the capsules in the morning and at night.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||A designated MD who is not involved in the study design, application, or interpretation will be available to unblind study participants when medically indicated|
|Official Title:||Functional Assessment of Ashwagandaha Root Extract During Weight Loss|
|Actual Study Start Date :||October 5, 2017|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Ashwagandaha Root Extract Capsule
Participants will take one 300 mg. Ashwaganda capsule twice a day for 12 weeks.
Drug: Ashwagandha Root Extract Capsule
Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.
Placebo Comparator: Placebo Capsule
Participants will take one placebo capsule twice a day for 12 weeks.
Drug: Placebo Capsule
Participants will take one placebo capsule orally twice a day for 12 weeks.
- Perceived Stress Scale PSS [ Time Frame: 12 weeks ]Standardized questionnaire
- Pittsburgh Sleep Quality Index PSQI [ Time Frame: 12 weeks ]Standardized questionnaire
- Food Craving Questionnaire - Trait FCQ-T [ Time Frame: 12 weeks ]Standardized questionnaire
- Three-Factor Eating Questionnaire TFEQ [ Time Frame: 12 weeks ]Standardized questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112824
|Contact: Peter Bastian, MDfirstname.lastname@example.org|
|Contact: Kristin M Bruhjell, BSemail@example.com|
|Principal Investigator:||Warren R Peters, MD MPH||LLU Administrator|