| CTRI Number |
CTRI/2021/09/036251 [Registered on: 06/09/2021] Trial Registered Prospectively |
| Last Modified On: |
03/09/2021 |
| 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
|
Study to evaluate the effect of Karshyahar Yoga Granules and Ksheer Bala Taila Matra Basti in Karshya w.s.r to Under Nutrition in Children |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Effect of Karshyahar Yoga Granules and Ksheer Bala Tail Matra Basti in Karshya w.s.r to Under Nutrition in 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 Minakshi Chaudhary |
| Designation |
Sr. Lecturer |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital |
| Address |
Department of Kaumarbhritya
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra 176115(H.P)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017565 |
| Fax |
|
| Email |
drminakshi2050@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital |
| Address |
Department of Kaumarbhritya
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra 176115(H.P)
VPO Ghumanhera, South West Delhi
New Delhi - 110073
South West
DELHI
110073
India |
| Phone |
8527214528 |
| Fax |
|
| Email |
nehavats1195@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital |
| Address |
Department of Kaumarbhritya
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola Kangra 176115(H.P)
South West
DELHI
110073
India |
| Phone |
8527214528 |
| Fax |
|
| Email |
nehavats1195@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Government Post Graduate Ayurvedic College And HospitalVPO Paprola District Kangra Himachal Pradesh 176115 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Government Post Graduate Ayurvedic College And Hospital |
| Address |
VPO Paprola District Kangra Himachal Pradesh 176115 |
| 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 Neha Vats |
Rajiv Gandhi Government Postgraduate Ayurvedic College And Hospital Paprola |
Department of Kaumarbhritya Room Number 217
Kangra
HIMACHAL PRADESH |
8527214528
nehavats1195@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics comittee(Human, RGGPG Ayurvedic college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E441||Mild protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karshyahar Yoga Granules |
130mg/kg/day with milk for 3 mnths |
| Comparator Agent |
Ksheer Bala Taila |
Matra Basti for 21 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patient between 2-16 yrs of age irrespective of sex with poor weight gain, lean and thin body as per IAP ( grade 1 and grade 2).
patient fulfilling the description of karshya described in our texts like sushka-sphika, sushka-udara, sushka-griva, Dhamani-jala darshanam. |
|
| ExclusionCriteria |
| Details |
patient suffering from severe malnutrition (grade3 and grade 4)
children with congenital anomaly.
children with chronic ailments like tuberculosis, malignancy, cardiac and renal problems.
children suffering from UTI, Diabetes mellitus and having physical disability. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in weight gain according to age |
Day 1, Day28, Day 56, Day91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in symptoms of Karshya like sushka sphika-udara-griva, dhamni jala darshanm |
Day1, Day 28, Day 56, Day91 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
18/09/2021 |
| 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
|
not available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nutrition is one critical factor which modulates the immune response, thus playing a crucial role in determining the outcome of an infectious illness. Further, morbidity and mortality dur to infectious illness are high among certain risk populations like low bith weight infants and malnourished children. in comparision to adult the nutrient requirement of children are 2-3 times higher because of their additional needs for growth. In India majority of children have weighs below the 50th percentile of NCHS standards. Underweight is defined as low weight for age and it is combined indicator to reflect both acute and chronic malnutrition. The condition can be correlated with karshya. Karshya being the Vata Pradhan Vyadhi, chikitsa like Brihmana, Rasayana, have been advocated in the classics for its management. Brimhana therapy is indicated in krishata to increase bulk of body. |