| CTRI Number |
CTRI/2025/07/090147 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Allopathic versus Ayurvedic Treatments for Major Depressive Disorder - A naturalistic study |
|
Scientific Title of Study
|
The SAFE Study: Clinical Effectiveness, Safety, and Health Evaluation of Allopathic versus Ayurvedic Treatments for Major Depressive Disorder: A Naturalistic Real-World Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr S N Gupta |
| Designation |
Distinguished Professor |
| Affiliation |
Maganbhai Adenwala Mahagujarat University |
| Address |
Department of Kayachikitsa
J. S. Ayurved Mahavidyalaya
College Road
Nadiad J. S. Ayurveda College Campus
College Road
Nadiad Kheda GUJARAT 387001 India |
| Phone |
9825261305 |
| Fax |
|
| Email |
guptayurveda@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Shivenarian Narsinghlal Gupta |
| Designation |
Distinguished Professor |
| Affiliation |
JS Ayurveda Mahavidyalaya and P D Patel Ayurveda Hospital |
| Address |
Room no. 101,
Department Of Kayachikitsa
P D Patel Ayurveda Hospital
J. S. Ayurved College Campus
College Road
Nadiad College Road
Nadiad
Gujarat Kheda GUJARAT 387001 India |
| Phone |
09825261305 |
| Fax |
0268 252 0724 |
| Email |
guptayurveda@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Manishkumar Vadilal Patel |
| Designation |
Professor & Head Department Of Kayachikitsa |
| Affiliation |
JS Ayurveda Mahavidyalaya and PD Patel Ayurveda Hospital |
| Address |
Room no. 102,
P D Patel Ayurveda Hospital
J. S. Ayurveda College Campus
College Road
Nadiad College Road
Nadiad
Gujarat Kheda GUJARAT 387001 India |
| Phone |
09979589865 |
| Fax |
0268 252 0724 |
| Email |
manishayu97@yahoo.com |
|
|
Source of Monetary or Material Support
|
| P D Patel Ayurveda Hospital
J S Ayurveda College Campus College Road Nadiad Dist Kheda Gujarat India Pincode
387001 |
| Shree krishna hospital Pramukhswami Medical College
Gokalnagar Karamsad Gujarat India Pincode 388325 |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda College |
| Address |
College Road
Nadiad, Gujarat
India
Pincode - 387001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Manishkumar Vadilal Patel |
P D Patel Ayurveda Hospital |
Room no. 102
OPD department of Kayachikitsa
J S Ayurved Mahavidyalaya Campus
College Road, Nadiad
Kheda
GUJARAT Kheda GUJARAT |
099795 89865
manishayu97@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bhaikaka University Institutional ethics committee |
Approved |
| Maganbhai Adenwala Mahagujarat University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F331||Major depressive disorder, recurrent, moderate. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
To be eligible for participation in this study potential participants must meet all of the following criteria
Gender and Age Participants must be adult females or males aged 18 to 65 years inclusive and be treated as in and or outpatients
Diagnosis Participants must have a primary diagnosis of Major Depressive Disorder MDD of moderate or severe severity as defined by clinician rating scales and clinical judgment according to DSM5 criteria Participants with active and current suicidality will be excluded
Prior Treatment Status Participants need to agree to start a new bout of allopathic or Ayurvedic treatment in the current episode regardless of any previous treatments received during the current episode
Informed Consent Participants must have the capacity to understand the study procedures and provide informed consent to participate They must also be willing to fully participate and adhere to the study protocol
These criteria aim to ensure a homogenous study sample to enhance the reliability and generalizability of study findings Any deviation from these criteria will be carefully documented and justified
|
|
| ExclusionCriteria |
| Details |
Individuals will be excluded from participation in this study if they meet any of the following criteria
Severe Psychiatric Comorbidity
Active Suicidality
Substance Use Disorder
Pregnancy or Breastfeeding
Significant Medical or Neurological Conditions
Communication Barriers
These exclusion criteria are designed to minimize confounding variables and ensure that the study results are interpretable and generalizable to a population of individuals with MDD who are otherwise relatively healthy Any deviations from these criteria will be carefully documented and justified
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint will focus on changes in depressive symptom severity, measured using three validated rating scales: the Hamilton Depression Rating Scale (HAM-D), the Montgomery-Åsberg Depression Rating Scale (MADRS), and the Patient Health Questionnaire-9 (PHQ-9).The use of multiple scales enhances the reliability and validity of the assessment, providing a more comprehensive picture of symptom change. Statistical analyses comparing changes in scores across treatment groups will be conducted to determine the relative efficacy of each intervention. |
Assessments will be conducted at baseline, bi-weekly for the first eight weeks, and then monthly until the six-month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| functional assessment and quality of life the fast clinical global impression cgi general assessment of functioning gaf and quality of life whoqolbref qlesqsf will be used to provide a detailed profile of functional status and disability this provides a patient centred perspective on treatment effectiveness complementing the clinician rated symptom severity measures |
Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up |
| adverse events the incidence and severity of adverse events will be meticulously recorded throughout the study period using a standardized adverse event reporting system uku gase this will allow for a direct comparison of the safety profiles of allopathic and ayurvedic treatments |
Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up |
| treatment adherence treatment adherence will be assessed using the medication adherence report scale mars5 supplemented by clinical judgment |
Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up |
| patient satisfaction patient satisfaction with treatment will be evaluated using a validated patient satisfaction questionnaire these measures will assess the acceptability and feasibility of each treatment approach |
Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up |
| daily functioning changes in daily functioning will be assessed using the global assessment of functioning gaf scale and the functional assessment short test fast it provides a quantitative measure of functional capacity in various domains eg social occupational and selfcare reflecting the impact of depression on daily life and the extent of functional recovery |
Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up |
| general health general health status will be assessed using measures such as body mass index bmi respiratory rate rr pulse ecg and comprehensive blood work such as liver function tests kidney function tests inflammatory markers such as crp leukocytes electrolytes blood tests and ecg will be taken at baseline and week 8 medical comorbidities will also be recorded allowing for adjustment in statistical analyses as needed |
Assessments will be conducted at baseline bi-weekly for the first eight weeks and then monthly until the six month follow up |
|
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmanishvpatel@mamuni.edu.in].
- For how long will this data be available start date provided 10-06-2025 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Major Depressive Disorder MDD a debilitating mood disorder characterized by persistent sadness anhedonia and impaired functioning poses a significant global health challenge While the precise etiology remains complex and multifaceted converging evidence points to a dysregulation of neurobiological systems interacting with environmental and psychosocial factors This interplay underscores the need for comprehensive treatment approaches that address both the biological and psychological dimensions of the disorder Current treatment strategies primarily utilize allopathic and increasingly complementary and alternative medicine CAM approaches such as Ayurvedic medicine Allopathic treatments for MDD predominantly focus on pharmacological interventions and various forms of psychotherapy Pharmacological treatments primarily involve antidepressants targeting neurotransmitter systems to alleviate depressive symptoms Selective serotonin reuptake inhibitors SSRIs serotonin norepinephrine reuptake inhibitors SNRIs tricyclic antidepressants TCAs and monoamine oxidase inhibitors MAOIs represent the main classes of antidepressants although their efficacy varies considerably between individuals Side effects including sexual dysfunction weight gain and sedation can limit treatment adherence and overall effectiveness Furthermore a substantial proportion of individuals exhibit treatment resistance necessitating alternative or augmentation strategies Psychotherapeutic interventions particularly cognitive behavioral therapy CBT and interpersonal psychotherapy IPT play a crucial role in modifying maladaptive thought patterns improving coping skills and enhancing interpersonal relationships These therapies often demonstrate comparable efficacy to antidepressants particularly in preventing relapse Ayurvedic medicine an ancient holistic system originating from India offers a complementary approach to MDD This system emphasizes the interconnectedness of mind body and spirit aiming to restore balance through various interventions These include herbal remedies eg Ashwagandha Brahmi dietary modifications tailored to individual constitution Prakriti lifestyle adjustments promoting holistic wellbeing and mind body techniques such as yoga and meditation While evidence level A and level B evidence studies and some smaller studies suggest the potential efficacy of Ayurvedic treatments in alleviating depressive symptoms robust largescale randomized controlled trials comparing Ayurvedic interventions to allopathic treatments are relatively scarce Understanding the mechanisms through which Ayurvedic interventions exert their effects on mood and related symptoms remains an area of active research This necessitates a more comprehensive understanding of the relative efficacy safety and potential synergistic effects of integrating allopathic and Ayurvedic treatments for MDD A comparative evaluation of these approaches is crucial for informing evidence based clinical practice and optimizing therapeutic strategies for individuals experiencing this pervasive and debilitating disorder This study aims to address this critical gap in the literature through observation and analysis of real world outcomes of Allopathic and Ayurvedic treatment modalities for MDD Review of literature Previous studies have shown that allopathic psychiatric medication can be combined safely with Ayurvedic treatments such as herbs Objectives of the present study Hypothesis and Objectives Based on the published literature we assume that both Allopathic and Ayurvedic treatments are efficacious Hence we do expect any statistically significant difference between the treatment groups in improving symptoms of depression over weeks However we hypothesise that all treatment groups lead to a statistically significant reduction in symptoms between baseline and week
This study will pursue the following scientific objectives Comparative Efficacy To quantitatively compare the efficacy of Allopathic and Ayurvedic treatments and their combination in reducing the severity of depressive symptoms in adults diagnosed with Major Depressive Disorder MDD as measured by validated rating scales eg Hamilton Depression Rating Scale HAMD Montgomery Åsberg Depression Rating Scale MADRS Patient Health Questionnaire PHQ at specified time points eg baseline weeks months months Statistical analyses eg ANOVA t tests will determine the significance of any differences in symptom reduction between treatment groups
Safety adverse Effects and Quality of Life To compare the incidence type and severity of adverse events associated with Allopathic and Ayurvedic treatments using standardized adverse event reporting Furthermore to assess differences in quality of life QoL and daily functioning between treatment groups using validated QoL instruments eg WHOQOLBREF and functional assessment scales eg Global Assessment of Functioning GAF Functional Assessment Short Test FAST Statistical analyses will determine the significance of any differences in adverse events and QoL outcomes between treatment groups
General Health Evaluation To evaluate and compare changes in general health parameters eg Body Mass Index BMI vital signs relevant blood work indicators such as liver and kidney function electrolytes CRP leukocytes histogram and TSH across treatment groups over the study duration Statistical analyses will assess for significant differences in general health outcomes between treatment groups
These objectives will be achieved through rigorous data collection methods and appropriate statistical analysis employing intention to treat principles to maximize the inclusion of collected data and enhance the generalizability of results The study will adhere to relevant ethical guidelines for the conduct of human subject research
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