Evaluation of Vamana and Virechana as Interventions to Decelerate the Aging Process in Healthy Adult Volunteers: Protocol for an Exploratory Single-Arm Clinical Trial.

چکیده اصلی

BACKGROUND: Vamana (therapeutic emesis) and Virechana (therapeutic purgation) are the two major biopurification procedures enlisted in Ayurveda. Studies explicitly showcasing their clinical efficacy are documented in substantial numbers. Ritu sodhana (seasonal purification) imparts rejuvenation in healthy individuals. However, its efficacy for health span and decelerating the aging process in healthy individuals remains a gray area. OBJECTIVE: This study's objective is to explore the effect of ritu sodhana on modifying serum levels of malondialdehyde (MDA), total superoxide dismutase (T-SOD), and telomerase activity. METHODS: The study was prospectively registered in the Clinical Trial Registry-India (CTRI; CTRI/2024/02/062176), uses a pre-posttest study design, and includes 53 participants 35 years to 65 years old. The study is exploratory and lacks a control group. Those with a BMI between 18.5 kg/m2 and 25 kg/m2, with stable weight for 3 months immediately prior to the study, with madhyama koshta (medium nature of bowel evacuation, as assessed using aquestionnaire), who are Vamanarha (eligible for therapeutic emesis) and Virechanarha (eligible for therapeutic purgation), and who do not meet the exclusion criteria will be included in the study. The interventions include emesis in the spring and purgation in the autumn season, preceded by Snehana (oleation) and Swedana (fomentation) and followed by the Samsarjana karma (specialized menu of diets) depending on the measurement of purification. Trial duration will range from 18 days to 20 days for each participant, and the total study duration will be 3 years. The serum levels of MDA, SOD, and telomerase activity will be measured on day 0 and on the next day following completion of the Samsarjana karma (18th-20th day). Continuous variables for primary biological endpoints including serum MDA, T-SOD, and telomerase activity will be evaluated using paired-samples t tests or Wilcoxon signed-rank tests, with potential missing data managed under a missing completely at random assumption using available case analysis (pairwise deletion) cross-verified by a conservative baseline observation carried forward (BOCF) sensitivity test. The effect size will be also determined. RESULTS: Recruitment began in March 2025. Data for 27 participants who voluntarily participated in Vasantha Vamana were collected in March 2025 and April 2025. Data analysis is pending, and the study is expected to be completed by the end of December 2026. CONCLUSIONS: The study will provide hypothesis-generating evidence, and the data will serve as a necessary precursor to adequately powered, confirmatory trials on the aging process.

ترجمه فارسی چکیده

وامانا (تثبیت ادرار) و ویرچانا (تثبیت مدفوع) دو روش اصلی تصفیه زیستی در آیورودا هستند. هدف این مطالعه بررسی اثر ریتو سودانا (تصفیه فصلی) بر تغییر سطح سرم مالون‌دی‌آلدئید (MDA)، سوپراکسید دی‌موتاز کل (T-SOD) و فعالیت تلومراز است. این مطالعه اکتشافی است و گروه کنترلی ندارد. مداخلات شامل استفراغ در بهار و دفع در پاییز است که با سنهانا (روغن‌دهی) و سویدانا (گرم کردن) همراه است. نمونه ۵۳ نفری (سن ۳۵ تا ۶۵ سال) شامل افرادی است که شرایط خاصی از جمله شاخص توده بدنی ۱۸.۵ تا ۲۵ و ماهیت متوسط دفع مدفوع دارند. اندازه‌گیری‌ها در روز ۰ و روز ۱۸ تا ۲۰ انجام می‌شود. نتایج تاکنون منتشر نشده است.

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