| CTRI Number |
CTRI/2024/03/063807 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| 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
|
A Randomized Controlled Trial on Assessment of the Efficacy of a Herbal Anaesthetic Gel for Painless Needle Prick in Neonates |
|
Scientific Title of Study
|
Assessment of the Anaesthetic Potential of Akarkarabha & Lavanga Gel During Venipuncture in Neonates: A Randomized Controlled Clinical Trial |
| 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 CHHAVI ROSHA |
| Designation |
PG SCHOLAR |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune |
| Address |
DEPARTMENT OF KAUMARABHRITYA, COLLEGE OF AYURVED, BHARATI VIDYAPEETH (Deemed to be University), KATRAJ DHANKAWADI CAMPUS, PUNE-SATARA ROAD, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
919671234022 |
| Fax |
|
| Email |
chhavi.rosha-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAHUL H GUJARATHI |
| Designation |
PROFESSOR & HEAD OF DEPARTMENT |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune |
| Address |
DEPARTMENT OF KAUMARABHRITYA, COLLEGE OF AYURVED, BHARATI VIDYAPEETH (Deemed to be University), KATRAJ DHANKAWADI CAMPUS, PUNE-SATARA ROAD, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
919420322740 |
| Fax |
|
| Email |
shrigujarathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAHUL H GUJARATHI |
| Designation |
PROFESSOR & HEAD OF DEPARTMENT |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved, Pune |
| Address |
DEPARTMENT OF KAUMARABHRITYA, COLLEGE OF AYURVED, BHARATI VIDYAPEETH (Deemed to be University), KATRAJ DHANKAWADI CAMPUS, PUNE-SATARA ROAD, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
919420322740 |
| Fax |
|
| Email |
shrigujarathi@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF KAUMARABHRITYA, COLLEGE OF AYURVED, BHARATI VIDYAPEETH (Deemed to be University), KATRAJ DHANKAWADI CAMPUS, PUNE-SATARA ROAD, PUNE |
|
|
Primary Sponsor
|
| Name |
DR CHHAVI ROSHA |
| Address |
DEPARTMENT OF KAUMARABHRITYA, COLLEGE OF AYURVED, BHARATI VIDYAPEETH (Deemed to be University), KATRAJ DHANKAWADI CAMPUS, PUNE-SATARA ROAD, PUNE |
| 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 CHHAVI ROSHA |
BHARATI AYURVED HOSPITAL, PUNE |
NICU, BHARATI AYURVED HOSPITAL, BHARATI VIDYAPEETH (Deemed to be University), KATRAJ DHANKAWADI CAMPUS, PUNE-SATARA ROAD, PUNE
Pune
MAHARASHTRA |
9671234022
chhavi.rosha-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE [BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Neonates scheduled to undergo venipuncture for medical evaluation. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Akarkarabha and Lavanga Gel , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Lidocaine Prilocaine Cream | Route: Topical, Dosage Form: Cream, Dose: 1(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1. Neonates who have completed 48 hours of life uneventfully post birth at the time of enrolment.
2. Neonates with a minimum weight of 2500 grams at the time of procedure.
3. Neonates born at or after 37 completed weeks of gestation.
4. Neonates free from major congenital abnormalities and are not on any life-support.
5. Neonates scheduled to undergo venipuncture for medical evaluation. |
|
| ExclusionCriteria |
| Details |
1. Neonates with skin lesions, or dermatological disorders.
2. Neonates receiving any concurrent systemic medications, other than the nutritional supplements.
3. Neonates born to mothers with compromised immune systems or mothers found positive for any communicable or infectious disease.
4. Neonates currently participating in other clinical trials.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of the study will be the assessment of "Pain Perception" experienced by the neonates during the venipuncture procedure.
The pain scores obtained from the scales will be the primary outcome to determine the anaesthetic potential of Akarkarabha and Lavanga topical gel in reducing pain perception during venipuncture in neonates. |
All assessments will be conducted at the following time points:
1. Baseline,
2. during venipuncture, and
3. post-procedure (30 minutes after the venipuncture procedure).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| As a secondary outcome, this study seeks to evaluate the incidence of sequelae or adverse events such as inflammation, erythema, oedema, alterations in skin integrity, localized infections, ecchymosis, delayed wound healing, & scar formation attributable to venipuncture within a 24-hour window following the application of Akarkarabha & Lavanga Gel at the venipuncture site. |
Within a 24-hour window following the application of Akarkarabha & Lavanga Gel at the venipuncture site. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/04/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pain management in neonatal care is crucial for ensuring optimal outcomes in vulnerable newborns undergoing common procedures, such as venipuncture. While synthetic topical anesthetics are conventionally used, their potential side effects in neonates necessitate exploration of alternative approaches. This study pioneers the investigation of Ayurvedic herbal remedies, specifically Akarkarabha and Lavanga, known for their pain-relieving properties. The study aims to assess a novel formulation’s anesthetic potential in reducing pain during venipuncture in neonates, comparing it to conventional topical anesthetic. If successful, this Ayurveda-based intervention could revolutionize neonatal care, offering a safe alternative to conventional anesthetics and opening new avenues for research in herbal medicine and anesthesia. Previous work on Akarkarabha and Lavanga highlights their potential, but there is a lack of direct assessment in neonatal pain management, forming the basis for this pioneering study. |