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CTRI Number  CTRI/2025/07/090411 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Screening 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic management of adolescent anxiety  
Scientific Title of Study   A COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF HINGWADI GHRITA AND MOORCHITA GHRITA PRATIMARSHYA NASYA FOR ADOLESCENTS IN THE MANAGEMENT OF GENERALIZED ANXIETY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishal Kawade 
Designation  PG Scholar 
Affiliation  Shree Jagadguru Gavisiddheswara Ayurvedic Medical College and hospital 
Address  Department of kaumarabhritya opd no 13 ground floor Shree Jagadguru Gavisiddheswara Ayurvedic Medical College post graduation studies and research centre, Koppal, Gavimat campus

Koppal
KARNATAKA
583231
India 
Phone  7387886149  
Fax    
Email  vishalnkawadepatil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Radhika Injamuri 
Designation  Associate Professor 
Affiliation  Shree Jagadguru Gavisiddheswara Ayurvedic Medical College and hospital 
Address  Department of kaumarabhritya opd no 13 ground floor Shree Jagadguru Gavisiddheswara Ayurvedic Medical College post graduation studies and research centre, Koppal, Gavimat campus

Koppal
KARNATAKA
583231
India 
Phone  9108304745  
Fax    
Email  raadhika17@outlook.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishal kawade 
Designation  PG Scholar 
Affiliation  Shree Jagadguru Gavisiddheswara Ayurvedic Medical College and hospital 
Address  Department of kaumarabhritya opd no 13 ground floor Shree Jagadguru Gavisiddheswara Ayurvedic Medical College post graduation studies and research centre, Koppal, Gavimat campus

Koppal
KARNATAKA
583231
India 
Phone  7387886149  
Fax    
Email  vishalnkawadepatil@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Vishal Kawade 
Address  Shree Jagadguru Gavisiddheswara Ayurvedic Medical College post graduation studies and research centre, Koppal, Gavimat campus 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NA  N/A 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishal Kawade  Shree Jagadguru Gavisiddheswara Ayurvedic Medical College and Hospital, Koppal  OPD No 13, Dept Of Kaumarabhritya
Koppal
KARNATAKA 
7387886149

vishalnkawadepatil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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: VATAJA-UNMADAH, (2) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: VATAJA-UNMADAH, (3) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: VATAJA-UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charaka Samhita, Procedure details: Pratimarshya nasya will be given for 30 days continue. twice a day time of administration : 2 drops will be instilled in each nostril for twice a day 1. In morning after dantdhawana 2. In evening (nishaha kala))
(1) Medicine Name: Hingwadi Ghrita, Reference: Bhaishajya Ratnavali, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: bd, Duration: 30 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charaka Samhita, Procedure details: Pratimarshya nasya will be given for 30 days continue. twice a day two drops will be instilled in each nostril for twice a day time of administration 1.In morning after dantdhawana 2.In evening(nishaha kala) )
(1) Medicine Name: Moorchita Ghrita, Reference: bhaishajya ratnavali, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Adolescent will be diagnosed for general anxiety aged between 12 to 18 years
according to the DSM-5 Diagnostic Criteria for Generalized Anxiety Disorder
irrespective of the gender religion caste and socioeconomical status 
 
ExclusionCriteria 
Details  Adolescents who are unfit for nasyakarma Adolescents who are already diagnosed
with depression and is on medication for the same.
Adolescents with other medical condition such as hyperthyroidism, diabetes or any
severe systemic illness 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
There is significant effect of Hingwadi ghrita pratimarshya nasya over moorchita ghrita
pratimarshya nasya in adolescents for the management of generalized anxiety. 
4 months 
 
Secondary Outcome  
Outcome  TimePoints 
There is no significant difference between the effect of Hingwadi ghrita pratimarshya
nasya and moorchita ghrita pratimarshya nasya in adolescent for the management of
generalized anxiety 
4 months 
 
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/ Phase 4 
Date of First Enrollment (India)   15/08/2025 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Adolescent age is the emotionally unstable age where majority of the drastic changes happens
in life such as onset of puberty, choosing career, failures, developing a sense of identity etc.
Such stressful events contribute to the development of anxiety.
Anxiety disorders are the most common psychiatric disorders of childhood occurring in 5 –
18 % of children and adolescents. The prevalence of generalized anxiety disorder ranges from
2.5 – 6% of children.2
The research studies has shown that there is a significant burden of anxiety disorders among
adolescents in India. As this burden of anxiety disorder can cause significant morbidity and
depression in future in the population, effective intervention should be planned to address
this. Simultaneously, the burden of other mental disorders should also be estimated in
adolescents in India. With respect to major depression, a worldwide survey reported that
45.7% of individuals with lifetime major depressive disorder had a history of one or more
anxiety disorder3 and among them 43% were with generalized anxiety disorder.4
In modern medicine anxiolytics such as, benzodiazepines, 5HT reuptake inhibitors
antidepressants, beta-adrenergic blockers are used to manage anxiety disorder but it has
severe adverse effects such as cerebral ataxia, drug dependence, withdrawal symptoms,
arrhythmia, hypotension, sexual dysfunction, drug toxicity in body etc.5 In many ayurvedic
samhitas it has stated that Nasya and shirodhara are the two major panchakarma process in
all types of urdhwajatrugata vikara. Nasya is found to be more effective than shirodhara in
the management of generalized anxiety6
It is coated that “Nasa hi sirso dwaram” and pratimarshya nasya is ajanma satmya to
everyone.7
Unmada is a group of different psychological disorders including including anxiety8,9.
Symptoms of generalized anxiety can be correlated with vataja unmada.
In many ayurvedic samhitas Hingwadi ghrita has been mentioned uder the unmada chikitsa
adhyaya 10,11,12,13, it is dipana, pachana, medhya, indriyaprasadak, vatahara gunas with
stimulant properties and it helps to balance vitiated doshas. The drug as whole is medhya,
ojasya, rasayana. Contents of hingwadi ghrita is effective against various CNS disorders.14
Ghrita is one of the nitya rasayanas,15 along with it is smritivardhaka,medhya,deepaa,ojasya,
and unmadahara. After the moorchana samskara over ghrita its efficacy gets increased by
thousand times and called as moorchita ghrita.16
Hence, if we prevent generalized anxiety disorder by ayurvedic management by pratimarshya
nasya in adolescents, then we will be able to deliver the healthy society in future.
 
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