| CTRI Number |
CTRI/2024/12/078295 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to know the effect of Ashta Choorna and diet modification in treating under nutrition in Children |
|
Scientific Title of Study
|
An Open labeled comparative clinical trial to Evaluate the effect of Ashta Choorna and diet modification in management of Karshya wsr to Grade I and II under nutrition in Children |
| 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 Archana Byahatti |
| Designation |
Assistant Professor Department of Kaumarabhritya |
| Affiliation |
Sanjeevini Ayurveda Medical College And Hospital, Gokul Road Hubballi 580030 |
| Address |
Sanjeevini Ayurveda Medical College And Hospital, Gokul Road Hubballi 580030
Dharwad
KARNATAKA
5800309
India |
| Phone |
7899589389 |
| Fax |
|
| Email |
archu.byahatti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Byahatti |
| Designation |
Assistant Professor Department of Kaumarabhritya |
| Affiliation |
Sanjeevini Ayurveda Medical College And Hospital, Gokul Road Hubballi 580030 |
| Address |
Sanjeevini Ayurveda Medical College And Hospital, Gokul Road Hubballi 580030
Dharwad
KARNATAKA
5800309
India |
| Phone |
7899589389 |
| Fax |
|
| Email |
archu.byahatti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Byahatti |
| Designation |
Assistant Professor Department of Kaumarabhritya |
| Affiliation |
Sanjeevini Ayurveda Medical College And Hospital, Gokul Road Hubballi 580030 |
| Address |
Sanjeevini Ayurveda Medical College And Hospital, Gokul Road Hubballi 580030
Dharwad
KARNATAKA
5800309
India |
| Phone |
7899589389 |
| Fax |
|
| Email |
archu.byahatti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjeevini Ayurveda Medical College and Hospital, Hubballi, Karnataka |
|
|
Primary Sponsor
|
| Name |
Sanjeevini Ayurveda Medical College And Hospital |
| Address |
Sanjeevini Ayurveda Medical College And Hospital, Gokul Road Hubballi 580030 |
| Type of Sponsor |
Private 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 Archana Byahatti |
Sanjeevini Ayurveda Medical College And Hospital |
Block I Room No 16 Department of Kaumarabhritya K S Sharma Campus Basawehwara nagar Gokul road Hubballi 580030
Dharwad
KARNATAKA |
7899589389
archu.byahatti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E440||Moderate protein-calorie malnutrition. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), (2) ICD-10 Condition:E40||Kwashiorkor. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashta Choorna, Reference: Ashtanga Hrudaya Gulma Chikitsa , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Samudga, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: with the diet modification as same as in Intervention arm | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: -, Ritucarya: -, Acara Rasayana:-, Other:-, Pathya/Apathya:yes, Pathya:1.200ml milk with one spoon sugar twice a day morning and evening
2.one bowl of sweet payasa with ghee once a day at morning
3. one bowl of kichadi with ghee twice a day at noon and night
4. one banana at bed time
above mentioned diet to be followed 45 days duration, Apathya:Avoiding Junck street fast food, spicy food, oily salty food maida freezed foods Braverages soft and cold drinks shold be completely avoided until the study duration |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Weight of child less than expected as per the age i.e. Grade 1 (71-80%) and Grade 2 (61-70%) according to IAP classification of Malnutrition.
BMI of 15-18.5%.
|
|
| ExclusionCriteria |
| Details |
Children having other acute & chronic systemic illnesses or requiring emergency management.
Children with developmental disorders like cerebral palsy intellectual disability etc.
Children with an inborn error of metabolism congenital abnormalities.
Children with neurobehavioral disorders like ADHD autism etc
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ashta Choorna along with diet style modification is effective in the management of Karshya
|
Baseline 15th day 30th day 45th day 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ashta choorna along with diet modification is effective when compared with only diet modification in the management of karshya |
Baseline 15th day 30th day 45th day 60th day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
31/12/2024 |
| 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 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 Study is comparative clinical trial to evaluate the effect of Ashta Choorna and Diet Modification in the children of age group 6years to 12 years of either gender with Grade I and Grade II undernutrition (Karshya) which will be conducted in Sanjeeevini Ayurveda Medical College and Hospital, Hubballi, Karnataka, India for a period of 1 year were the subjects will be enrolled based on the inclusive criteria and assessments of anthropometric parameters and subjective criteria will be done on 0th 15th 30th 45th and 60th day later the obtained data will be recorded tabulated and analysed statistically were we are expect that ashta choorna and diet modification might be effective in the management of karshya. |