Evaluation of comparative efficacy of Celastrus paniculatus (Jyotishmati) capsule versus sertraline capsule in the management of Chittodvega (generalized anxiety disorder): protocol for a randomized controlled trial.

Q2 Pharmacology, Toxicology and Pharmaceutics F1000Research Pub Date : 2024-10-28 eCollection Date: 2023-01-01 DOI:10.12688/f1000research.139473.2

Reeya Gamne, Sadhana Misar, Mayank Rai

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Abstract

Background: Generalized anxiety disorder (GAD) (Chittodvega) is one among many types of mental disorders explained in Ayurveda. It can be defined as a Chitta (mind) + Udvega (anxiety)= Chittodvega- Anxious status of a mind. Celastrus paniculatus also known as Jyotishmati stimulates and improves the digestive fire and metabolism at a cellular level ( Jatharagni and Majja dhatwagni). It can be correlated to GAD. GAD is characterized by feelings of threat, restlessness, irritability, sleep disturbance, and tension, and symptoms such as palpitations, dry mouth, and sweating. It affects women more frequently than men and prevalence rates are high in midlife (prevalence in females over age 35: 10%) and older subjects. In modern medicine the first-line psychological and pharmaceutical treatments are selective serotonin reuptake inhibitors (SSRIs) like sertraline (SNRIs).

Aim and objectives: To evaluate the comparative efficacy of Jyotishmati versus sertraline in the management of Chittodvega.

Methods: In this randomized active controlled double blind equivalence trial a total of 70 patients will be enrolled and divided into two equal groups. Patients between 20-50 years age of either gender having symptoms of Chittodvega and a Hamilton anxiety rating (HAM-A) scale score less than 24 (i.e., mild to moderate) will be selected for the study. In Group A, sertraline capsules 25 mg for first 7 days and then dose increased to 50 mg at bedtime for next 53 days and in Group B Jyotishmati Capsules 500 mg will be given twice a day after food with water for 60 days.

Result and observation: The patients will be assessed on the HAM-A scale, serum cortisol and WHO Quality of Life on day 0, 30, 60 and 90 and data will be analyzed using paired and unpaired t-tests for continuous variables and chi-square tests for categorical variables to evaluate whether treatments are equivalent.

Trial registration: CTRI No. REF/2023/07/069880 Date - 15/09/2023.

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在治疗 Chittodvega（广泛性焦虑症）方面，评估青蒿（Jyotishmati）胶囊与舍曲林胶囊的疗效对比：随机对照试验方案。

背景介绍广泛性焦虑症（GAD）（Chittodvega）是阿育吠陀中解释的多种精神障碍之一。它可以定义为 Chitta（心灵）+ Udvega（焦虑）= Chittodvega--心灵的焦虑状态。青蒿又名 Jyotishmati，能刺激和改善细胞层面的消化系统和新陈代谢（Jatharagni 和 Majja dhatwagni）。它可与 GAD 相关联。焦虑症的特点是感到威胁、烦躁不安、易怒、睡眠障碍和紧张，以及心悸、口干和出汗等症状。它对女性的影响比男性更常见，在中年（35 岁以上女性的发病率为 10%）和老年患者中发病率较高。在现代医学中，一线心理和药物治疗是选择性血清素再摄取抑制剂（SSRIs），如舍曲林（SNRIs）：评估 Jyotishmati 与舍曲林治疗 Chittodvega 的疗效比较：在这项随机对照双盲等效试验中，将招募 70 名患者，并将其分为两组。研究将选择年龄在 20-50 岁之间、有 Chittodvega 症状且汉密尔顿焦虑评分（HAM-A）小于 24 分（即轻度至中度）的男女患者。在 A 组中，头 7 天服用 25 毫克舍曲林胶囊，然后将剂量增至 50 毫克，睡前服用，持续 53 天；在 B 组中，每天两次，饭后用水送服 Jyotishmati 胶囊 500 毫克，持续 60 天：将在第 0、30、60 和 90 天对患者进行 HAM-A 量表、血清皮质醇和世卫组织生活质量评估，并使用配对和非配对 t 检验对连续变量进行数据分析，使用卡方检验对分类变量进行数据分析，以评估治疗效果是否相同：CTRI 编号：REF/2023/07/069880 日期：2023 年 9 月 15 日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

F1000Research Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

5.00

自引率

0.00%

发文量

1646

审稿时长

1 weeks

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