| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: ANAVASTHITACITTATVAMĀ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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- |
|
|
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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 |