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CTRI Number  CTRI/2025/03/082407 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Clinical Study of Ashtamangal Ghrita and Brahmi Ghrita in Management of Generalized Anxiety Disorder (Vishada) 
Scientific Title of Study   A double blind randomized comparative clinical study to evaluate the efficacy of Ashtamangal Ghrita and Brahmi Ghrita in the management of generalized anxiety disorder (Vishada)  
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 Neha Khandelwal 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda , Deemed to be University , Jaipur , Rajasthan 
Address  Department of Kayachikitsa ,National Institute Of Ayurveda ,Deemed to be university ,Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8118833594  
Fax    
Email  nehakhandelwal096@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharat Kumar Padhar 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda , Deemed to be University , Jaipur , Rajasthan 
Address  Department of Kayachikitsa ,National Institute Of Ayurveda ,Deemed to be university ,Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9638435942  
Fax    
Email  bcpadhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neha Khandelwal 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda , Deemed to be University , Jaipur , Rajasthan 
Address  Department of Kayachikitsa ,National Institute Of Ayurveda ,Deemed to be university ,Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8118833594  
Fax    
Email  nehakhandelwal096@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda, Deemed to be University , Jaipur 302002 rajasthan , India 
 
Primary Sponsor  
Name  Nationnal Institute Of Ayurveda, Deemed to be university, Jaipur 
Address  National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh Gate, Amer road Jaipur, Rajasthan 302002 India 
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 Neha Khandelwal  National Institute of Ayurveda, Deemed to be university, Jaipur, Hospital  OPDs of Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India Jaipur RAJASTHAN
Jaipur
RAJASTHAN 
8118833594

nehakhandelwal096@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics comittee National Institute of Ayurveda Deemed to be university (De-Novo)(Ministery of Ayush Govt of India )Jorawar singh gate amer road jaipur 302002   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: VISHADAH/DINATA (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Brahmi Ghrita , Reference: BHAVA PRAKASH APASMARA ROGADHIKARA 23/18 , Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Luke Warm Water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Ashtamangal ghrita, Reference: BHAISAJYA RATNAVALI 71/135 , Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex between the age of 20–60 years, Fulfilling DSM V diagnostic criteria for GAD
and willing to participate in the study and having any sign and symptoms of Generalized Anxiety Disorder and Vishada will be included in the study. 
 
ExclusionCriteria 
Details  Patients with symptoms of co-morbid psychiatric disorders, on psychotropic drugs, doing substance abuse like alcohol, tobacco , opium etc.
and who having significant depression and other medical serious systemic diseases like cancer, tuberculosis etc and uncontrolled Hypertension, Diabetes Mellitus and dyslipidemia will be excluded in the study.
Pregnant and lactating women will be excluded from the study.
Having history of hypersensitivity or allergy to study drugs, Severe renal impairment (eGFR less than 30 mL/min/1.73 m²),Hepatic impairment (aspartate aminotransferase or alanine aminotransferase more than 2 times the upper limit of normal), Uncontrolled hypertension (systolic blood pressure more than 180 mmHg or diastolic blood pressure more than 100 mmHg)and Presence of any other serious medical condition that may interfere with study participation will be excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study will be the Change in Hamilton’s anxiety rating scale.  From Base line(0th day)to 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Pittsburgh Sleep Quality Index (PSQI)
Change in Serum Cortisol level
Change in symptoms of Vishada.  
From Base line(0th day)to 28th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   01/05/2025 
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="1"
Months="6"
Days="28" 
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  

Generalized Anxiety Disorder (GAD), a prevalent mental health condition characterized by excessive worry and anxiety, can significantly impact daily functioning and quality of life if left untreated. While pharmacological interventions exist, Ayurveda offers alternative and complementary therapies with potential efficacy and fewer side effects. The concept of "Vishada," as described in the Shreemad Bhagavad Gita, particularly in the Arjuna Vishada Yoga, aligns with anxiety symptoms such as trembling, sweating, dry mouth, body shaking, goosebumps, burning sensations, apprehension, and fear of future events. Acharya Sushruta classified "Vishada" as a "Manasa roga" (mental disorder) in the Sushruta Samhita, with Dalhan further explaining it as a state of despair due to fear of failure. Similarly, Acharya Charaka examined Vishada in "Viman Sthan" and categorized it as a "Nanatamaj Vataj Vikara." This study aims to compare the efficacy of Ashtamangala Ghrita and Brahmi Ghrita in managing Generalized Anxiety Disorder (Vishada). The objectives include assessing their impact on Hamilton’s Anxiety Rating Scale, Pittsburgh Sleep Quality Index (PSQI), and serum cortisol levels, along with their effects on symptoms of Vishada and GAD. The null hypothesis (H0) states no difference in efficacy between the two formulations, whereas the alternative hypothesis (H1) suggests a difference. This Phase 2, single-center, randomized, double-blind, comparative clinical study will involve 60 patients over 28 days (4 weeks). Statistical analysis will include Mean, Standard Deviation, and Standard Error (SE), with intra-group assessment using the Wilcoxon matched-pairs signed ranks test for non-parametric data and the paired t-test for parametric data. Inter-group comparisons will utilize the Mann-Whitney test for non-parametric variables and the unpaired t-test for parametric variables.

 
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