| CTRI Number |
CTRI/2024/01/062027 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of swetasarshapa oil nasya on anxiety. |
|
Scientific Title of Study
|
A Pharmaco-clinical Study Of Shwetasarshapa (Brassica campestris (Linn.)) Oil Nasya To Access Anxiolytic Effects As An Add On Therapy In The Management Of Anxiety Neurosis |
| 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 Pankaj P Surve |
| Designation |
PhD Scholar |
| Affiliation |
MUHS Nashik and NCIM NewDelhi |
| Address |
Dept of Dravyagunshastra Loknete Rajarambapu Patil Ayurvedic Medical College And Hospital located in Uran Islampur
Dept of Dravyagunshastra Loknete Rajarambapu Patil Ayurvedic Medical College And Hospital located in Uran Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
8446211662 |
| Fax |
02342661212 |
| Email |
dr.pankajps@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Prasanna Gavali |
| Designation |
Professor and HOD |
| Affiliation |
MUHS Nashik and NCIM NewDelhi |
| Address |
Dept of Dravyagunshastra Loknete Rajarambapu Patil Ayurvedic Medical College And Hospital Islampur Sangli
Dept of Dravyagunshastra Loknete Rajarambapu Patil Ayurvedic Medical College And Hospital Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9921638074 |
| Fax |
02342661212 |
| Email |
prasanna_gavali@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Prasanna Gavali |
| Designation |
Professor & HOD |
| Affiliation |
MUHS Nashik and NCIM NewDelhi |
| Address |
Dept of Dravyagunshastra Loknete Rajarambapu Patil Ayurvedic Medical College And Hospital located in Uran Islampur
Dept of Dravyagunshastra Loknete Rajarambapu Patil Ayurvedic Medical College And Hospital located in Uran Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9921638074 |
| Fax |
02342661212 |
| Email |
prasanna_gavali@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Sahu Maharaj Shikshan Sansthan Ayurved Mahavidyalaya Kancahnwadi Aurangabad |
|
|
Primary Sponsor
|
| Name |
Dr Pankaj P Surve |
| Address |
CSMSS Ayurved Mahavidyalaya Paithan road Kanchanwadi Aurangabad |
| Type of Sponsor |
Other [self sponcer] |
|
|
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 Pankaj Surve |
CSMSS Ayurved Mahavidyalaya and Hospital |
OPD of Manasroga 13th No Ground floor
kanchanwadi
Paithan road
Aurangabad
Aurangabad
MAHARASHTRA |
84446211662
02402646464
dr.pankajps@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| CSMSS Institutional Ethics |
No Objection Certificate |
| LRP Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F418||Other specified anxiety disorders. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brassica campestris Linn., Reference: Charaksamhita Sushrutasamhita Madanpalanighantu, Route: Nasal, Dosage Form: Taila, Dose: 8(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: cap.Librium, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 10(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: cap.Librium, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 10(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Intervention |
Group-I
(Trial group)
|
Nasya of trial drug Oil + Standard care of treatment
Chlordiazepoxide (Cap. Librium 10mg)
|
| Intervention |
Group-II
(Comparison group) |
Standard care of treatment
i.e. Chlordiazepoxide (Cap. Librium 10mg) |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnosed case of Anxiety neurosis
No discrimination of sex, race, caste and religion
Onset between 8 weeks and 2years
Subjects with known standard care of treatment
Subjects with history of Diabetes mellitus type 2 and mild Hypertension |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of Schizophrenia
Subjects showing repeated Panic attack
Subjects diagnosed as Medication-induced anxiety disorder, panic disorders, Post traumatic
Stress Disorder
Subjects having Specific phobia, Agoraphobia or any other chronic systemic disease as
Irritable Bowel Syndrome Severe Kidney Disease
Pregnant and Lactating women |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reductions in symptoms HAMA Scale of Anxiety |
0th day, 8th day, 15th days amd 45thday |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in symptoms of anxiety |
after 45 days |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr_pankajps@rediffmail.com].
- For how long will this data be available start date provided 01-09-2023 and end date provided 31-08-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - dr_pankajps@rediffmail.com
|
|
Brief Summary
|
The Study includes two groups Trial Group and Comparison
Group.
Trial group:
The patients Shall be given Nasya of trial
drug Oil and Chlordiazepoxide (Cap. Librium 10mg) for 45 days.The Dose of Nasya
oil shall be in the form of marshya
nasya 3ml to 5 ml in each nostril as per body constituents (Prakruti) for 7
days and from 8th day onwards patients shall be given 1ml of pratimarshya nasya till 45th day
and Cap. Librium orally 10mg twice a day
for total duration of 45 days.
Comparison Group (Group-II) :
The patients Shall be given Chlordiazepoxide(Cap.
Librium 10mg) twice a day for duration of 45 days.
Route of administration: Nasal route for
trial drug. And Oral route for Cap.Librium for Comparison Group.
Outcome: The Trial drugs shall be
helpful for reducing the signs and symptoms of the patient of Anxiety Neurosis.
Primary outcome will be the clinical
parameters observed during study using scale used of HAM-A.
Duration of Study: Total Duration of
Study will be 45 days. |