A Clinical Trial to Study the effect of Kanakatuka Vati in Malnourished Underweight Children

Phase 2

Not yet recruiting

Conditions: Moderate protein-calorie malnutrition, (2) ICD-10 Condition: E440||Moderate protein-calorie malnutrition,

Registration Number: CTRI/2019/06/019585

Lead Sponsor: State Ayurvedic College and Hospital Lucknow

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

.Children between 2 to 6 year of either sex.
.Children of grade I and II according to IAP .Classification of malnutrition.

Exclusion Criteria

.Children age less than 2 year and more than 6 year .Children of grade III and IV malnutrition.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
.Improvement in loss of appetite	.2 weeks \| .4 weeks
.Effective weight gain	.2 weeks \| .4 weeks
.Effective in fever	.2 weeks \| .4 weeks

Secondary Outcome Measures

Name	Time	Method
.Effective weight gain	.Effective in cough

Trial Locations

Locations (1): State Ayurvedic College and Hospital and Lucknow UniversityLucknow
🇮🇳
Lucknow, UTTAR PRADESH, India
State Ayurvedic College and Hospital and Lucknow UniversityLucknow
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Jyoti
Principal investigator
9565067051
jyotiraj1909@gmail.com