| CTRI Number |
CTRI/2019/06/019585 [Registered on: 10/06/2019] Trial Registered Prospectively |
| Last Modified On: |
08/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to Study the effect of Kanakatuka Vati in Malnourished Underweight Children |
|
Scientific Title of Study
|
A Clinical Controlled Trial on Kanakatuka Vati to improve Nutritional Status in Malnourished Underweight 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 Jyoti Singh |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
PG Department of Kaumarabhritya State Ayurvedic College and Hospital Lucknow
State Ayurvedic College and Hospital Near Khala Bazar Police Station Tudiyaganj Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9565067051 |
| Fax |
|
| Email |
jyotiraj1909@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi |
| Designation |
Asst. Professor |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
PG Department of Kaumarabhritya State Ayurvedic College and Hospital Lucknow
State Ayurvedic College and Hospital Near Khala Bazar Police Station Tudiyaganj Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9792446688 |
| Fax |
|
| Email |
lakshmiomsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi |
| Designation |
Asst. Professor |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
PG Department of Kaumarabhritya State Ayurvedic College and Hospital Lucknow
State Ayurvedic College and Hospital Near Khala Bazar Police Station Tudiyaganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9792446688 |
| Fax |
|
| Email |
lakshmiomsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital and Lucknow University Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
State Ayurvedic College and Hospital Near Khala Bazar Police station Lucknow |
| 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 Jyoti |
State Ayurvedic College and Hospital and Lucknow UniversityLucknow |
Deptt of Kaumarabhritya opd no 2 State Ayurvedic College and Hospital Tulsidas marg Lucknow pincode 226003 Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH |
9565067051
jyotiraj1909@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee State Ayurvedic College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E440||Moderate protein-calorie malnutrition, (2) ICD-10 Condition: E440||Moderate protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
.Trial drug-Kanakatuka Vati |
.Oral administration of
10-20mg/kg/day in divided doses for 30days with madhu and ghrit |
| Comparator Agent |
Controlled drug- Hyderabad mixture |
Oral administration of 80gm mixture in a day for 30 days |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
.Children between 2 to 6 year of either sex.
.Children of grade I and II according to IAP .Classification of malnutrition.
|
|
| ExclusionCriteria |
| Details |
.Children age less than 2 year and more than 6 year
.Children of grade III and IV malnutrition. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
.Improvement in loss of appetite
.Effective weight gain
.Effective in fever |
.2 weeks
.4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.Effective weight gain
.Effective in cough
|
.4 weeks
.2-3 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/06/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Malnutrition is steadily becoming a big public health problem. Although malnutrition is associated with lack of food and poverty,it is also seen in economically advantaged families probably because of lack of awareness in the parents about proper child nutrition. The trial drug (Kanakatuka vati) is a unique combination of Kutki and Pippali mentioned in Astanga Sangraha for the treatment of Vyadhi Balshosha (underweight child) .Thus to improve the nutritional status in malnourished children the present study is framed. Aim of the study is to evaluate the Role of Kanakatuka vati in malnourished underweight children, to compare the effect of controlled drug(HRM) with and without trial drug, to findout association between Srotodusti and malnutrition.Present study also include a survey to assess the nutritional status and effect of malnutrition on child’s wellbeing in a population consisting of children aged 2-6 years. It is a randomized Parallel group active controlled trial. Inclusion criteria- Children between 2-6 yearsof either sex and having grade I and grade II according to IAP classification of malnutrition. Plan of study- 60 children of 2-6 year of age will be register irrespective of sex from OPD and school’s near by SAC and H Lucknow and divided in to 3 groups. Trial drug Kanakatuka vati will be given to group A in a dose of 10-20mg/kg body weight in divided doses with madhu and ghrit for 30 days. Controlled drug (HRM) will be given to group B in a dose of 80gm in a day. Group C receive both Kanakatuka vati and HRM. Follow up will be done at 15th day and 30th day during trial and at 30th day after trial. Assessment - The result of clinical study will be assessed on the basis of improvement in subjective and objective parameters before and after trial. Observations documented during study will be statistically analyzed to establish efficacy. |