| CTRI Number |
CTRI/2025/04/085298 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Lakshadi Taila Abhyanga For Weight Gain In Low Birth Weight Newborns |
|
Scientific Title of Study
|
Randomized Controlled Trial To Evaluate The Efficacy Of Lakshadi Taila Abhyanga For Weight Gain In Low Birth Weight Neonates Greater Than Or Equal to 35 Weeks Gestational Age |
| 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 Harshada Sanjay Sonawane |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya |
| Address |
OPD number 4, kaumarbhritya department , siddhakala ayurved mahavidyalaya, pimparane road, sangamner,ahmadnagar, maharashtra, India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9284632617 |
| Fax |
|
| Email |
drharshada23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Arjun Hase |
| Designation |
Professor in Kaumarbhritya |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya |
| Address |
OPD number 4, kaumarbhritya department , siddhakala ayurved mahavidyalaya, pimparane road, sangamner,ahmadnagar, maharashtra, India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9960688468 |
| Fax |
|
| Email |
drpramodhase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Arjun Hase |
| Designation |
Professor in Kaumarbhritya |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya |
| Address |
OPD number 4, kaumarbhritya department , siddhakala ayurved mahavidyalaya, pimparane road, sangamner,ahmadnagar, maharashtra, India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9960688468 |
| Fax |
|
| Email |
drpramodhase@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurved Mahavidyalaya,Pimparane Road, Sangmaner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605 |
|
|
Primary Sponsor
|
| Name |
Harshada Sanjay Sonawane |
| Address |
Siddhakala Ayurved Mahavidyalaya,Pimparane Road, Sangmaner Khurd, Sangamner, Ahilyanagar, Maharashtra, India, 422605 |
| 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 Harshada Sanjay Sonawane |
Siddhakala Ayurved Mahavidyalaya, Sangamner |
OPD number 4, kaumarbhritya department , siddhakala ayurved mahavidyalaya, pimparane road, sangamner,ahmadnagar, maharashtra, India 422605
Ahmadnagar
MAHARASHTRA |
09284632617
drharshada23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurved Research and Statistics Committee of Siddhakala Ayurved Mahavidyalaya, Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:P073||Preterm [premature] newborn [other]. Ayurveda Condition: BALAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Simyl MCT Oil | Simyl MCT Oil 10 ml BD , for Local Application For 5-7 Minutes | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lakshadi Taila, Reference: Ashtanga Hridaya Uttarsthana Chapter No. 2, Shloka No. 54, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -Vyano Udan Kala |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonate Weighing Between 1.5 To 2.5 Kg Of Birth Weight, Neonate Between The Ages From Birth To 28 Days Irrespective Of Gender,Cast, Religion, Socio-economic Status, Gestational Age More Than Or Equal To 35 Weeks |
|
| ExclusionCriteria |
| Details |
Neonate Associated With Skin Conditions Like Open Wound, Severe Eczema, Dermatitis, Sepsis, Any Congenital Anomalies Like Spina Bifida, Diphragmatic Hernia, Anencephalya, In Born Error Of Metabolism Like Phenylketonuria, Maple Syrup Urine Disease, Galactosemia, Systemic Diseases Like Necrotizing Enterocolitis, Broncho Pulmonary Dysplasia, Meningitis, Neonate With Pathological Jaundice |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Effect Of 10ml Lakshadi Taila Abhyanga At Morning And Evening In Low Birth Weight Neonate More Than 35 Weeks Of Gestational Age |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine The Impact Of Lakshadi Taila Abhyanga On Skin Health In Low Birth Weight Neonate , To Assess The Impact Of Lakshadi Taila Abhyanga On Maintaining Stable Body Temperature In Low Birth Weight Neonate, Evakuate The Safety Of Lakshadi Tail Abhyanga In Low Birth Weight Neonate. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
29/04/2025 |
| 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 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 An Open Labelled Randomised Controlled Clinical Trial Comparing The Safety And Efficacy Of Lakshadi Taila In A Sufficient Quantity (10ML) For Local Application And Controlled Drug Simyl MCT Oil In A Sufficient Quantity (10ML) For 15 Days In 70 Patients Of Low Birth Weight Neonate Greater Than Or Equal To 35 Weeks Gestational Age For Weight Gain. |