| CTRI Number |
CTRI/2022/03/040798 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
02/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Panchgavya Ghrita Nasya and Shankhapuspi kwatha dhara in Chittodvega (Anxiety) |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF PANCHAGAVYA GHRITA NASYA AND SHANKHAPUSPI KWATHA DHARA IN THE MANAGEMENT OF CHITTODVEGA W.S.R. ANXIETY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Sharma |
| Designation |
PG Scholar |
| Affiliation |
V.Y.D.S.Ayurveda mahavidyalaya, khurja |
| Address |
OPD NO 19 PG Department of Panchkarma V Y D S A M Khurja
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8824606006 |
| Fax |
|
| Email |
ravisharma78622@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish Narain Rai |
| Designation |
M.D. and HOD |
| Affiliation |
V.Y.D.S.Ayurveda mahavidyalaya, khurja |
| Address |
OPD NO 19 PG Department of Panchkarma V Y D S A M Khurja
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9417448850 |
| Fax |
|
| Email |
girishnarainrai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Sharma |
| Designation |
PG Scholar |
| Affiliation |
V.Y.D.S.Ayurveda mahavidyalaya, khurja |
| Address |
OPD NO 19 PG Department of Panchkarma V Y D S A M Khurja
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8824606006 |
| Fax |
|
| Email |
ravisharma78622@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Pyarelal Ramdutt Vaidya Chikitsalaya
Dharapa, Khurja Bulandshahr (UP) |
|
|
Primary Sponsor
|
| Name |
Vaidya Yagya Dutt Sharma Ayurved mahavidyalya |
| Address |
Dharpa Khurja Bulandshahr Road Khurja Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Sharma |
vaidya yagya dutt sharma ayurved mahavidyalya |
OPD no. 19 department of Panchkarma vaidya yagya dutt sharma ayurved mahavidyalaya dharpa khurja bulandshahr road khurja utter pradesh
Bulandshahar
UTTAR PRADESH |
8824606006
ravisharma78622@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Ethical Committee, Khurja |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: CHITTODVEGA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: CHARAK SAMHITA, SHUSHRUTA SAMHITA, Procedure details: 8 BINDU OF PANCHAGAVYA GHRITA IN ACH NOSTRIL WILL BE ADMINISTERED DAILY IN THE MORNING)
(1) Medicine Name: PANCHAGAVYA GHRITA, Reference: CHARAK SAMHITA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | SHIRO DHARA | (Procedure Reference: ACHARYA KASTURE, Procedure details: SHIRODHARA FOR 30 MINUTES DAILY IN THE MORNING)
(1) Medicine Name: SHANKHAPUSPI KWATHA, Reference: CHARAK SAMHITA, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1500(ml), Frequency: od, Duration: 15 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the DSM IV-TR diagnostic criteria for anxiety
patients who score at least 14 on the hamilton anxiety rating scale |
|
| ExclusionCriteria |
| Details |
a)patients with alcohol dependency or drug dependency were excluded from the study
b)patients having a chronic illness like asthma malignancies liver cirrhosis chronic renal failure diabetes
c)patients with an acute illness like CVA CCF MI COPD meningitis acute pain conditions and similar other disorders |
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
none
mild
moderate
severe
severe grossly disabling |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
none
mild
moderate
severe
severe grossly disabling |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/03/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
in this trial, we are selecting the patients of chittodvega (anxiety), in which we will do the intervention in two groups( 15 patients in each groups), group I - 15 patients 8 bindu of panchagavya ghrita in each nostril will be administered for 15 days daily in the morning followed by a gap 7 days than again same process will be repeated for 15 days. group II - 15 patients will be treated with shankhapuspi kwatha sirodhara for 30 minutes daily in the morning for 15 days with the gap of 7 days again same process will be repeated for 15 days. assessments should be done on the basis of primery and secondry outcome pre and post treatment, as discussed earlier. |