| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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. |