| CTRI Number |
CTRI/2024/12/078450 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study effect of lakshadi tail abhyanga in preterm babies for normal growth |
|
Scientific Title of Study
|
Randomized controlled trial to study effect of lakshadi tail abhyanga in late preterm babies for normal growth |
| 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 Asmita Vaijinath Chaudhari |
| Designation |
MD scholar Kaumarbhrityatantra |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
7083519180 |
| Fax |
|
| Email |
asmitachaudhari26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Jagtap |
| Designation |
lecturer of department of Kaumarbritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8412022555 |
| Fax |
|
| Email |
Manisha.shinde18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Jagtap |
| Designation |
lecturer of department of Kaumarbritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
MAHARASHTRA
411028
India |
| Phone |
8412022555 |
| Fax |
|
| Email |
Manisha.shinde18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Asmita Vaijinath Chaudhari |
sane guruji arogya kendra |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA |
7083519180
asmitachaudhari26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
late preterm babies of gestational age 34.1 weeks to 36.6 weeks with birth weight in between 1800 to 2400 gms |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: cocconut oil, Reference: Bhavprakash, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -Treatment will be given for 1 month. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lakshadi tail, Reference: Bhaishajyaratnavali Balrogadhikar, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -Treatment will be given for 1 month |
|
|
|
Inclusion Criteria
|
| Age From |
8.50 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
Neonates with gestational age equal to 34.1 weeks to 36.6 weeks.3
Neonates with birth weight in between 1800gm to 2400gm.
Babies who are haemodynamically stable.
Neonates who are on full feed.
Those who are passing patch test will be included
Both male and female child will include in this study
Parents who will give informed written consent those baby will be
included in the study
|
|
| ExclusionCriteria |
| Details |
Neonates having respiratory distress Hypoglycemia those who are
receiving supplementary oxygen ventilatory support and having
neurological problems
Neonates with major congenital anomalies at birth like cleft palate cleft
lip imperforated anus diaphragmatic hernia cyanotic heart disease
Tracheo oesophageal fistula
Those who are having neonatal sepsis Jaundice fever will be excluded
Those are having skin disorders will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study effect of lakshadi tail abhyanga in late preterm babies for normal growth |
Treatment will be given for 1 month
Abhyanga will be done for once in a day for 1 month
Follow up and assessment will be done pre treatment and 5th 15th 30th 45th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Literature study of akala prasut balak in both modern & ayurvedic textbook |
Study will be done using Ayurvedic Granthas & modern text preparation of drugs will be done according to standard procedure
During treatment observation will be done on day 5th 15th 30th 45th day for any adverse effect on patient |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is a randomized controlled trial to study efficacy of lakshadi tail and coconut oil abhyanga in late preterm babies for normal growth .Primary objective is to study the efficacy of lakshadi tail abhyanga in late preterm babies for normal growth by giving abhyanga for 1 month . Assessment of babies will be done on the basis of anthropometry parameters. Follow up and assessment will be on 5th 15th 30th and 45th day of life. |