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CTRI Number  CTRI/2024/07/070878 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 18/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study to assess the efficacy of Ayurvedic formulation and Cognitive Behavioural Therapy in managing Generalized Anxiety Disorder 
Scientific Title of Study   The efficacy of Saraswatham choornam as an add-on to Cognitive behavioural therapy in improving the symptoms of Generalized anxiety disorder- A randomized clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shifana P M 
Designation  Pg Scholar 
Affiliation  Vaidyaratnam Ayurveda College Thaikkattussery, Ollur 
Address  Department of Kayachikitsa Vaidyaratnam Ayurveda College Thaikkattussery Ollur Thrissur

Thrissur
KERALA
680306
India 
Phone  8138861619  
Fax    
Email  shifanapm19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T C Marikutty  
Designation  Professor and HOD  
Affiliation  Vaidyaratnam Ayurveda College Thaikkattussery, Ollur 
Address  Department of Kayachikitsa Vaidyaratnam Ayurveda College Thaikkattussery, Ollur

Thrissur
KERALA
680306
India 
Phone  9447829212  
Fax    
Email  drmarikuttytc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr T C Marikutty  
Designation  Professor and HOD  
Affiliation  Vaidyaratnam Ayurveda College Thaikkattussery, Ollur 
Address  Department of Kayachikitsa Vaidyaratnam Ayurveda College Thaikkattussery, Ollur

Thrissur
KERALA
680306
India 
Phone  9447829212  
Fax    
Email  drmarikuttytc@gmail.com  
 
Source of Monetary or Material Support  
Vaidyaratnam Ayurveda College, Thaikattussery, Ollur, Thrissur, kerala, India, Pin code- 680306 
 
Primary Sponsor  
Name  Vaidyaratnam Ayurveda college 
Address  Vaidyaratnam Ayurveda College Thaikattussery, Ollur Thrissur-680306 
Type of Sponsor  Other [Aided 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 Shifana P M  Vaidyaratnam Ayurveda College, Ollur  Room No 1 Vaidyaratnam Ayurveda College OPD, Thaikattusery Ollur, Thrissur
Thrissur
KERALA 		 8138861619

shifanapm19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vaidyaratnam Ayurveda College, Thaikattussery, Ollur, Thrissur  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
1Comparator Arm (Non Ayurveda)-Cognitive Behavioural Therapy5 sessions of Cognitive behavioural therapy giving for both groups on 1st, 7th, 14th, 21st, and 28th day
2Intervention ArmDrugClassical(1) Medicine Name: Saraswatham Churnam, Reference: Vangasena samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: 4 gm Madhu and 8 gm ghrutha-), Additional Information: -5 sessions of Cognitive behavioral therapy will be given for both groups on the 1st, 7th, 14th, 21st, and 28th days.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Clinically diagnosed cases of Generalized Anxiety Disorder based on ICD10 Criteria
2.20- 50 age group irrespective of gender, caste, religion and economic status.
3.Diagnosis should be confirmed by a specialist in Manasikaroga Vijnana 
 
ExclusionCriteria 
Details  • Patients with psychiatric disorder & other systemic and metabolic disorders
• Drug abuse and withdrawal patient.
• Pregnant women, Lactating women.
• Participants having completed any other trial within 6 months.
• Patients taking allopathic medications for GAD
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Changes in the anxiety scoring of Hamilton Anxiety Rating Scale.
• Changes in manasabhava scale score
 		 At 0th, 28th and 35th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in manasabhava scale score  On 1st, 28th and 35 th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   29/07/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Generalized anxiety disorder is characterized by persistent uncontrolled worry for more than 6 months about everyday things which could be multifocal and presented with many psychological and physical symptoms. Cognitive behavioural therapy and medications are the two main treatments. In this study, 40 subjects aged 20 to 50 years diagnosed with ICD 10 Criteria are divided into two groups of 20 participants each. Both groups are provided with 5 sessions of Cognitive behavioural therapy. One group will be given Ayurvedic medicine Saraswatham choornam 4gm with 8 gm of ghrutha and 4gm of madhu BD after food. The allocation will be concealed using the snooze technique. Outcome will be collected using a direct personal interview method and will be assessed by Hamilton anxiety rating scale and Manasabhava scale. Statistically tested using parametric and non-parametric tests. 
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