| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: UNMADA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | saravA~gga, सरà¥à¤µà¤¾à¤‚ग | (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 | | 2 | Intervention Arm | Procedure | - | 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
- 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 - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [liyanr@gwu.ac.lk].
- 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.
- 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.
|