| CTRI Number |
CTRI/2024/11/076448 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
STUDY TO FIND ANXIOLYTIC AND SEDATIVE ACTION OF PARIJATA FLOWER ARKA IN PRE OPERATIVE PATIENTS |
|
Scientific Title of Study
|
A DOUBLE BLIND RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE ANXIOLYTIC AND SEDATIVE EFFECT OF PARIJATA PUSHPA ARKA IN PRE OPERATIVE PATIENTS |
| 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 Bhagya Shaji |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharamasthala Manjunatheshwara College of Ayurveda , Hospital and Research Centre |
| Address |
Department of PG Studies in Shalyatantra
Sri Dharamasthala Manjunatheshwara College of Ayurveda , Hospital and Research Centre
Kuthpady, Udupi, Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
8129151481 |
| Fax |
|
| Email |
bhagyashaji95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh R N |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharamasthala Manjunatheshwara College of Ayurveda , Hospital and Research Centre |
| Address |
Department of PG Studies in Shalyatantra
Sri Dharamasthala Manjunatheshwara College of Ayurveda , Hospital and Research Centre
Kuthpady, Udupi, Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
9449753320 |
| Fax |
|
| Email |
rakesharyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagya Shaji |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharamasthala Manjunatheshwara College of Ayurveda , Hospital and Research Centre |
| Address |
Department of PG Studies in Shalyatantra
Sri Dharamasthala Manjunatheshwara College of Ayurveda , Hospital and Research Centre
Kuthpady, Udupi, Karnataka
Udupi
KARNATAKA
574118
India |
| Phone |
8129151481 |
| Fax |
|
| Email |
bhagyashaji95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi, 574118 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Bhagya Shaji |
| Address |
PG Scholar
Department of PG Studies in Shalyatantra
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi, 574118 Karnataka, India |
| 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 Bhagya Shaji |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi |
Shalya Thantra departement OPD Room Number- 5 and 4 IPD
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi, 574118 Karnataka, India
Udupi
KARNATAKA |
8129151481
bhagyashaji95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE- HUMAN Managed by SHRI DHARMASTHALA MA NJUNATHESHWARA EDUCATIONAL SOCIETY UJIRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: SASTRAKARMA-APACARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Parijata Pushpa Arka, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: As a pre-operative medicine | | 2 | Comparator Arm (Non Ayurveda) | | - | Distilled Water as placebo | 20 patients selected as control group will be given with 10 ml of distilled water as placebo for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex aged between 18-60 years
2.Patients posted for elective surgery |
|
| ExclusionCriteria |
| Details |
1.Patient consuming antipsychiatry medicines
2.Patient consuming sedative or analgesic medicines |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Study to evaluate anxiolytic activity and sedative effect of parijata pushpa arka in patient posted for surgery.
2.To estimate the minimization of anesthetic drug and post operative analgesic |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
13/11/2024 |
| 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="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 - NO
|
|
Brief Summary
|
This study is a doble blind randomized controlled clinical study to evaluate the anxiolytic and sedative effect of Parijata Pushpa Arka in pre operative patients. the patients will be randomly divided into two groups each group of 20 patients. total participants of 40. Group A recruited subjects will be administered with Parijata Pushpa Arka 10 ml and Group B recruited subjects will be administered with distilled water 10 ml. the study will be conducted at Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi, Karnataka. Al patients will be requested to complete the Amsterdam Pre operative Anxiety and Information Scale ( APAIS) and sedation level will be measured using Richmond Agitation Sedation Scale (RASS). Hence this study is an effort to evaluate the anxiolytic and sedative effect of Parijata Pushpa Arka as a pre operative medicine in patients. |