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 [version 3; peer review: 2 approved, 1 approved with reservations]

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 d...

Full description

Saved in:
Bibliographic Details
Main Authors: Sadhana Misar, Mayank Rai, Reeya Gamne
Format: Article
Language:English
Published: F1000 Research Ltd 2024-10-01
Series:F1000Research
Subjects:
Online Access:https://f1000research.com/articles/12-1577/v3
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1850200897313832960
author Sadhana Misar
Mayank Rai
Reeya Gamne
author_facet Sadhana Misar
Mayank Rai
Reeya Gamne
author_sort Sadhana Misar
collection DOAJ
description 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
format Article
id doaj-art-9e59ae98b1dc4e2dbced718cdc4730ad
institution OA Journals
issn 2046-1402
language English
publishDate 2024-10-01
publisher F1000 Research Ltd
record_format Article
series F1000Research
spelling doaj-art-9e59ae98b1dc4e2dbced718cdc4730ad2025-08-20T02:12:10ZengF1000 Research LtdF1000Research2046-14022024-10-011210.12688/f1000research.139473.3173733Evaluation 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 [version 3; peer review: 2 approved, 1 approved with reservations]Sadhana Misar0https://orcid.org/0000-0003-0165-0171Mayank Rai1https://orcid.org/0000-0002-2519-5620Reeya Gamne2https://orcid.org/0000-0002-8960-2977Department Kayachikitsa, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, IndiaDepartment Kayachikitsa, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, IndiaDepartment Kayachikitsa, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, IndiaBackground 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 – 15/09/2023https://f1000research.com/articles/12-1577/v3Chittodvega Celastrus paniculatus GAD HAM-A Scale Jyotishmati Medhyaeng
spellingShingle Sadhana Misar
Mayank Rai
Reeya Gamne
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 [version 3; peer review: 2 approved, 1 approved with reservations]
F1000Research
Chittodvega
Celastrus paniculatus
GAD
HAM-A Scale
Jyotishmati
Medhya
eng
title 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 [version 3; peer review: 2 approved, 1 approved with reservations]
title_full 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 [version 3; peer review: 2 approved, 1 approved with reservations]
title_fullStr 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 [version 3; peer review: 2 approved, 1 approved with reservations]
title_full_unstemmed 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 [version 3; peer review: 2 approved, 1 approved with reservations]
title_short 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 [version 3; peer review: 2 approved, 1 approved with reservations]
title_sort 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 version 3 peer review 2 approved 1 approved with reservations
topic Chittodvega
Celastrus paniculatus
GAD
HAM-A Scale
Jyotishmati
Medhya
eng
url https://f1000research.com/articles/12-1577/v3
work_keys_str_mv AT sadhanamisar evaluationofcomparativeefficacyofcelastruspaniculatusjyotishmaticapsuleversussertralinecapsuleinthemanagementofchittodvegageneralizedanxietydisorderprotocolforarandomizedcontrolledtrialversion3peerreview2approved1approvedwithreservations
AT mayankrai evaluationofcomparativeefficacyofcelastruspaniculatusjyotishmaticapsuleversussertralinecapsuleinthemanagementofchittodvegageneralizedanxietydisorderprotocolforarandomizedcontrolledtrialversion3peerreview2approved1approvedwithreservations
AT reeyagamne evaluationofcomparativeefficacyofcelastruspaniculatusjyotishmaticapsuleversussertralinecapsuleinthemanagementofchittodvegageneralizedanxietydisorderprotocolforarandomizedcontrolledtrialversion3peerreview2approved1approvedwithreservations