| CTRI Number |
CTRI/2024/12/077570 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Sarasvata ghrita & its nasya in management (Generalized anxiety disorder) |
|
Scientific Title of Study
|
CLINICAL EFFICACY OF SARASVATA GHRITA & ITS NASYA IN CHITTODVEGA (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 |
Sumit Kumar |
| Designation |
P G Scholar |
| Affiliation |
Quadra Institute of Ayurveda And Hospital Roorkee |
| Address |
Opd No 2 Department of kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
7017020316 |
| Fax |
|
| Email |
choudharysumit801@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajnikant Rohilla |
| Designation |
Professor & H O D |
| Affiliation |
Quadra Institute of Ayurveda And Hospital Roorkee |
| Address |
Opd No 2 Department of kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
8557076363 |
| Fax |
|
| Email |
drrajnikant83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumit Kumar |
| Designation |
P G Scholar |
| Affiliation |
Quadra Institute of Ayurveda And Hospital Roorkee |
| Address |
Opd No 2 Department of kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee
Hardwar
UTTARANCHAL
247667
India |
| Phone |
7017020316 |
| Fax |
|
| Email |
choudharysumit801@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUMIT KUMAR opd no 2 DEPARTMENT OF P.G.KAYACHIKITSA QUADRA INSTITUTE OF AYURVEDA AND HOSPITAL Nh58 ROORKEE Haridwar Road Near Montfort SCHOOL,Roorkee(Haridwar)India 247667 |
|
|
Primary Sponsor
|
| Name |
SUMIT KUMAR |
| Address |
Opd No 2 Department of kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee(Haridwar)India 247667 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sumit Kumar |
Quadra Institute Of Ayurveda And Hospital |
Opd No 2 Department Of kayachikitsa quadra institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee (Haridwar)
Hardwar
UTTARANCHAL |
07017020316
choudharysumit801@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE QUADRA INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarasvata Ghrita , Reference: Bhava Prakasha Madhyama Khanda Vatavyadhyadhikara (ch24/46-47), Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: Sarasvata Ghrita in a dose of 10 ml will be given orally with the lukewarm water twice a day for 45 days | | 2 | Comparator Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Charak Samhita Siddhi Sthan ch 9/116, Procedure details: It is performed by gentle massage over the face then by dipping the little finger in the Ghrita & insertion into 2 drops of Sarasvata Ghrita in each nostrill. )
(1) Medicine Name: Sarasvata Ghrita , Reference: Bhava Prakasa Madhyama Khanda Vatavyadhikara (ch 24/46-47), Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. patient willing to participate in the trial and sign the consent form.
2. Individuals between the age group of 18-50 years will be selected.
3. Individual having classical sign and symptom of chittodvega (Generaliosed anxiety disorde) |
|
| ExclusionCriteria |
| Details |
1. Patient not willing for trial.
2. patient below the age 18years and above 50 years will be excluded.
3.Patient suffering from any other concomitant like-thyroid dysfunction, Diabetes mellitus, and heart disease.
4.Patent suffering from any other psychiatric illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SARASVATA GHRITA ORALLY AND ITS NASYA SHOWED CLINICALLY SIGNIFICANT EFFECT IN MANAGING CHITTODVEGA (GENERALIZED ANXIETY DISORDER) |
FIRST FOLLOW UP - AFTER 15 DAYS OF FIRST TRIAL.
SECOUND FOLLOW UP-15 DAYS AFTER FIRST FOLLOW UP
THIRD FOLLOW UP- 15 DAYS AFTER SECOUND FOLLOW UP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CLINICAL EFFICACY OF SARASVATA GHRITA & ITS NASYA IN CHITTODVEGA
9GENERALISED ANXIETY DISORDER) |
ASSESSMENT WILL BE DONE ON 0 DAY AND 45 DAYS. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
18/12/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
THIS IS THE OPEN LABEL CLINICAL STUDY CLINICAL EFFICACY OF SARASVATA GHRITA AND ITS NASYA IN CHITTODVEGA (GENERALISED ANXIETY DISORDER). This study will be conducted in two group, First group A SARASVATA GHRITA ORALLY in Dose Of 10 ML Twice a day with luke warm water on Empty Stomach will be Given. Secound group B NASYA OF SARASVATA GHRITA Instillation of two drop in each Nostril in the morning hours before meals will be given for a period of time 45 days. Total 40 patient will be registered 20 patient in each group for this study from the OPD/IPD of Quadra institute of ayurveda Roorkee Uttrakhand.will be selected for this study. th patient between the age group of 18-50 years of age .This period of study is 18 month and duration of study 45 days. |