| CTRI Number |
CTRI/2023/04/051393 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Use of coconut and its substance as a nutritional supplement for children. |
|
Scientific Title of Study
|
A clinical study to assess the Balya and Pushtikar effect of Narikela Khanda in undernourished children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lowkesh Chandravanshi |
| Designation |
Lecturer |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
| Address |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827822231 |
| Fax |
|
| Email |
lowkeshc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyawati Rathia |
| Designation |
Lecturer |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
| Address |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9924975823 |
| Fax |
|
| Email |
satirathiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyawati Rathia |
| Designation |
Lecturer |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
| Address |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India |
| Phone |
9924975823 |
| Fax |
|
| Email |
satirathiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
|
|
Primary Sponsor
|
| Name |
Department of Kaumarabhritya Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
| Address |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
| Type of Sponsor |
Government medical college |
|
|
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 Akanksha Mishra |
Shri Khudadad Doongaji Government Ayurved Hospital |
Department of Kaumarabhritya OPD NO. 7 and IPD patient Shri Khudadad Doongaji Government Ayurved Hospital Raipur Chhattisgarh 492010 Raipur CHHATTISGARH
Raipur
CHHATTISGARH |
9406331441
akankshamishra281096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE PRINCIPAL, SHRI NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Narikela Khanda, Reference: Bhaishajya Ratanavali Shoolarogadhikar shlok no. 235-241, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Milk), Additional Information: -Avoiding milk will be advised with medication after consuming non-vegetarian food. |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with BMI between 4th and 50th percentile.
2.Underweight Children (low weight for age).
3.Children will be selected irrespective of socioeconomic status. |
|
| ExclusionCriteria |
| Details |
1.Chronic infectious disorder.
2.Congenital hereditary problems.
3.Malignancies.
4.Systemic illness-Juvenile Diabetes mellitus ,cardiac disease , Renal disease.
5.Children with BMI percentile less than 4th and more than 50th percentile.
6.Worm infestation. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight gain in patients and overcome weakness. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve quality of life. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/04/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nutrition is important at every age. Eating a nutritious diet helps keep a healthy body, weight and a healthy heart and brain. Term undernutrition includes stunting, wasting and underweight. Karshya is raswaha shrotas disease. Narikela Khanda contain high percentage of calories, carbohydrates and protein hence it will play an important role in the nervous system. Lauric acid is the key ingredient in all the coconut products. Narikela Khandha provides nourishment, improves appetite and increases strenghth, it is a mild formulation that can be used in children as well as old age people for overcoming weakness and disability. Follow up will be done every 15 days. Post treatment follow up will be done every 15 days for 1 month. Assessment will be done on the basis of subjective and objective criteria adopted for this study. |