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CTRI Number  CTRI/2024/08/073067 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of a Selected Treatment Protocol in the Management of Anxiety 
Scientific Title of Study   Effectiveness of an Integrated Treatment Protocol in the Management of Chittodvega w.s.r. to Generalised Anxiety Disorder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ruwan Priyantha Liyanage 
Designation  Postgraduate Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Manovijnana Evum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital B.M. Road, Thanniruhalla, Hassan. Karnataka-573201, India

Hassan
KARNATAKA
573201
India 
Phone  6361928882  
Fax    
Email  liyanr@gwu.ac.lk  
 
Details of Contact Person
Scientific Query
 
Name  Savitha H P 
Designation  Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Manovijnana Evum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital B.M. Road, Thanniruhalla, Hassan. Karnataka-573201, India

Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  savithem@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Savitha H P 
Designation  Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Manovijnana Evum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital B.M. Road, Thanniruhalla, Hassan. Karnataka-573201, India

Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  savithem@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital B.M. Road, Thanniruhalla, Hassan, Karnataka - 573201, India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  B.M. ROAD, THANNIRUHALLA, HASSAN, KARNATAKA - 573201, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruwan Priyantha Liyanage  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  Department of Manovijnana Evum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital B.M. Road, Thanniruhalla, Hassan. Karnataka 573201, India
Hassan
KARNATAKA 
6361928882

liyanr@gwu.ac.lk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: UNMADA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-saravA~gga, सर्वांग  (Procedure Reference: Ashtanga Hridaya Samhita Sutrasthana Sneha Adhyaya, Procedure details: 30 minutes per day for 5 days using luke warm ksheerabala taila)
(1) Medicine Name: Ksheerabala Taila, Reference: Ayurveda Pharmacopeia of India, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 5 Days
2Intervention ArmProcedure-pariSheka, परिषेक (Procedure Reference: Ashtanga Hridaya Samhita Sweda Adhyaya, Procedure details: 30 minutes per day for 5 days)
(1) Medicine Name: Dashamula Kwatha, Reference: Ayurveda Pharmacopeia of India, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants irrespective of gender
Participants between 18 and 60 years of age irrespective of socio-economic status
Participants willing to give informed consent and comply with study procedures
 
 
ExclusionCriteria 
Details  Pregnant and lactating female
Participants suffering from comorbid psychiatric disorders
The individuals those who are unable to undergo with the selected treatment protocol
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Hamilton Anxiety Rating Scale  Hamilton Anxiety Rating Scale will be Used to Assess the cases before treatment 0th day and at the end of treatment 5th day 
 
Secondary Outcome  
Outcome  TimePoints 
Galvanic Skin Response  At before treatment in day 0 & at the end of treatment day 5 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="37" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   10/09/2024 
Date of Study Completion (India) 31/10/2025 
Date of First Enrollment (Global)  10/09/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [liyanr@gwu.ac.lk].

  6. For how long will this data be available start date provided 10-09-2024 and end date provided 01-09-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The term Chittodvega correlated with the symptomatological explanation of Generalised Anxiety Disorder (GAD). The global prevalence of anxiety disorders in 2019 was 4.05%. Medications that widely use in anxiety have been found with considerable amount of adverse drug events. Both psychotherapy and pharmacotherapy have been shown to be more effective in previous research studies. Therefore, the study is planned with a combination of Sarvanga abhyanga with Ksheerabala oil, Sarvanga Parisheka with Dashamula Kwatha, Thakradhara, Ashwagandha and Yashtimadhu churna with milk, Shiva panchakshari mantra japa listening, Buddhist meditation and Psychotherapy for a period of five days. All the interventions planned in the study have already depicted positive impact separately in the management of Chittodvega w.s.r to GAD and current study expects to observe the combined effect of the selected protocol. Main objective of this study is to evaluate the effectiveness of integrated treatment modality in Chittodvega W.S.R. to Generalised Anxiety Disorder. The study will be an open labeled single arm clinical trial in the inpatient department at Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan. Data will be collected using specially prepared case report forms, irrespective of caste, sex and religion. Sample size is 35. Participants will be diagnosed on the basis of 6B00 Generalised Anxiety Disorder ICD-11.  Participants who are willing to give informed consent and comply with study procedures irrespective of gender and socio-economic status and between 18-60 years of age will be included and pregnant and lactating females, individuals with comorbid psychiatric disorders and those who are unable to undergo with the selected treatment protocol will be excluded. Hamilton Anxiety Rating Scale and Galvanic Skin Response will be used for the assessment at 0th day before treatment, 03rd day at treatment and 06th day after the treatment. The data will be analyzed using an appropriate statistical software.

 
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