None listed
Conditions
Interventions
Intervention1: Ashwagandha-Turmeric Herbal Tea: Ashwagandha-Turmeric Herbal Tea: Serving Size- 2g (tea bag) in 150 ml hot water, 5 mins brewing at about to boil water.
Recommended consumption: Consump
Sponsors
Luxmi Tea Co Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male and Female adults aged 18 to 65 years both inclusive Generally healthy individuals, as determined by medical history and physical examination Self-reported stress levels, indicated by a score of 14 or more on the Perceived Stress Scale PSS Participants should have a score less than 15 on the World Health Organization five WHO 5 well being index Willing and able to provide written informed consent before any study-related procedures. This ensures that participants understand the study purpose, procedures, risks, and benefits and that their participation is voluntary Participants must be daily tea taker, willing and able to comply with all study procedures, including daily consumption of the assigned tea Ashwagandha Turmeric Herbal Tea or Normal tea prepared as per direction provided and continuing for the duration of the study, attending scheduled study visits, and completing all required questionnaires and subject diaries. Access to a telephone and the ability to be contacted by study personnel Agreement to maintain a stable diet throughout the study period Day 0 to completion of 8 weeks and not undertake any major dietary changes Participants should be free of psychiatric conditions other than stress, as determined by medical history and the investigator. Agreement to discontinue the use of any other herbal supplements or stress-reducing interventions aromatherapy, meditation for at least 2 weeks before enrolment and throughout the study duration. Participants should not be enrolled in any other trials, or planned surgery during the study period
Exclusion criteria
Exclusion criteria: Known allergy or sensitivity to Ashwagandha, turmeric, or other ingredients in the herbal tea Current use of antidepressant, anti anxiety, or sleep altering medications Use of anticoagulant or antiplatelet medications Use of immunosuppressant medications Use of thyroid hormone medication, unless the condition is stable for at least 6 months Under diagnosis of any major psychiatric disorder History of significant gastrointestinal disease Pregnant or breastfeeding women Uncontrolled hypertension or unstable cardiovascular disease Uncontrolled diabetic patients Hyperthyroidism or uncontrolled hypothyroidism Participation in another clinical trial within the past 30 days. Subjects with a score of 15 or higher on the World Health Organization five WHO 5 well being index Any other significant medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study or could interfere with the interpretation of the study results. Participants were currently taking any herbal preparations or formulations containing Ashwagandha, ginseng, ginkgo biloba, Brahmi, or related herbs Participants suffering from any chronic physical, hormonal, or psychiatric illness Participants with abnormal laboratory or ECG findings Participants having any substance dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Ashwagandha-Turmeric Herbal Tea in reducing perceived stress levels in healthy adults compared to normal teaTimepoint: Baseline and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the impact of Ashwagandha-Turmeric Herbal Tea on anxiety levels compared to normal tea To evaluate the effect of Ashwagandha-Turmeric Herbal Tea on sleep quality compared to normal tea To explore the changes in general well-being and quality of life in participants consuming Ashwagandha-Turmeric Herbal Tea compared to normal tea To assess the safety and tolerability of Ashwagandha-Turmeric Herbal Tea compared to normal teaTimepoint: Baseline and 8 weeks;Exploratory Endpoint To evaluate the effect of Ashwagandha Turmeric Herbal Tea on cortisol levels compared to normal teaTimepoint: Baseline and 8 weeks | — |
Countries
India
Contacts
Public ContactSushavan Sinha
Luxmi Tea Co Private Limited
Outcome results
None listed