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CTRI Number  CTRI/2025/02/081353 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A Clinical study on add-on effectiveness of Matsyakshi Kalka (Alteranthera sessilis linn.) as shiro thalam in chittodvega w.r.t. Generalized Anxiety Disorder 
Scientific Title of Study   A CLINICAL STUDY ON ADD-ON EFFECTIVENESS OF MATSYAKSHI SHIRO THALAM (Alteranthera sessilis L.) IN CHITTODVEGA W.R.T. GENERALIZED 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  Dr Koni Nithin Kumar 
Designation  PG Scholar in Dept of Manovigyana and Manasaroga 
Affiliation  SDM College of Ayurveda and Hospital, Hassan 
Address  Department of Manoviyana evum Manasaroga, OPD-8, SDM College of Ayurveda and Hospital, Thanneeruhalla, hassan - 573201
Department of Manoviyana evum Manasaroga, OPD-8, SDM College of Ayurveda and Hospital, Thanneeruhalla, hassan - 573201

KARNATAKA
573201
India 
Phone  09964450778  
Fax    
Email  nithinkumar.koni@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Savitha H P  
Designation  Professor, Dept of Manovigyana and Manasaroga 
Affiliation  SDM College of Ayurveda and Hospital, Hassan 
Address  Department of Manoviyana evum Manasaroga, OPD-8, SDM College of Ayurveda and Hospital, Thanneeruhalla, hassan - 573201
Department of Manoviyana evum Manasaroga, OPD-8, SDM College of Ayurveda and Hospital, Thanneeruhalla, hassan - 573201
Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  savithem@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Savitha H P  
Designation  Professor, Dept of Manovigyana and Manasaroga 
Affiliation  SDM College of Ayurveda and Hospital, Hassan 
Address  Department of Manoviyana evum Manasaroga, OPD-8, SDM College of Ayurveda and Hospital, Thanneeruhalla, hassan - 573201
Department of Manoviyana evum Manasaroga, OPD-8, SDM College of Ayurveda and Hospital, Thanneeruhalla, hassan - 573201

KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  savithem@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanneeruhalla, Hassan - 573201 
 
Primary Sponsor  
Name  SDM College of Ayurveda and Hospital 
Address  SDM College of Ayurveda and Hospital, Thanneeruhalla, hassan - 573201 
Type of Sponsor  Research institution and hospital 
 
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 Koni Nithin Kumar  SDM COLLEGE OF AYURVEDA AND HOSPITAL  OPD - 8, DEPARTMENT OF MANOVIYANA EVUM MANASAROGA, SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, THANNEERUHALLA, BM ROAD, HASSAN - 573201
Hassan
KARNATAKA 
9964450778

nithinkumar.koni@gmail.com 
 
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, HASSAN  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: ANAVASTHITACITTATVAMĀ (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: MATSYAKSHI, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 25(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: FOR 90 MINUTES EVERYDAY FOR 7 DAYS-
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participants between 18 to 70 years of age.
Participants assessed with mild to moderate anxiety in HAM A scale 
 
ExclusionCriteria 
Details  Participants with acute substance intoxication.
Participants under various psychotropic medications.
Menstruating and pregnant female participants.
Participants with allergic infections, scalp psoriasis, tinea versicolor, respiratory disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Matsyakshi shirothalam helps in the management of Generalized Anxiety Disorder  At baseline and 8 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of matsyakshi shorothalam in the management of Chittodvea w.r.t. Generalized Anxiety Disorder  At baseline & 8 days 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/03/2025 
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)
Modification(s)  
Open to Recruitment 
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 - NO
Brief Summary  

Generalised Anxiety Disorder (GAD) is defined as excessive anxiety and worry about several events or activities for most days than not during at least a 6-month period GAD is becoming more prevalent in general population with its prevalence ranges from 3-8% annually, with around 25% of individuals seeking psychological help exhibiting symptoms of GAD Globally, approximately 3.6% of the population suffers from anxiety disorders with India having a weighted prevalence of 0.57% The symptoms of GAD include excessive anxiety and worry difficulty controlling the worrying restlessness irritability trouble concentrating sleeplessness having a sense of impending danger along with some somatic symptoms such as palpitations sweating trembling or shaking nausea or abdominal distress etc If left unchecked in the course of time GAD might lead to psychosomatic disorders such as like irritable bowel syndrome depression insomnia drug or alcohol use disorder gastrointestinal problems and may even impair the quality of life ultimately resulting in suicide potential In contemporary science anxiety is tackled with the use of anti-depressants and benzodiazepines which on chronic use leads to physiological dependence short-term cognitive and psychomotor impairment and rebound anxiety upon discontinuation Chittodvega is a manovikara explained in the classics of Ayurveda  which is a literal combination of Chitta and Udvega which means anxious state of mind. Chittodvega is efficiently treated with various Ayurvedic therapies with reflective benefits One such unique therapy mentioned is Murdhni taila that includes Shiro Abhyanga Seka Pichu and Basti Shiro Thalam is a modified form of Shiro lepa used extensively in Kerala for treating various shiro and manasa rogas where in the ground paste of medicinal herbs are applied over the vertex of the head for a stipulated period of time

Matsyakshi Thalam (Alteranthera sessilis; Amaranthaceae family) has been practiced by Sri Lankan Vaidyas as an indigenous therapy in treating anxiety disorders Matsyakshi is an abundantly available herb in southern India, used in the local practice of Karnataka in promoting the intelligence Matsyakshi is known for its central nervous system stimulating action anxiolytic  property nootropic property and anti-depressant activity Here in this study an attempt has been made to evaluate the efficacy of Matsyakshi Thalam particularly its probable mode of action in treating GAD

 
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