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CTRI Number  CTRI/2025/04/084793 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 11/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study on effect of polyherbal formulations in underweight children  
Scientific Title of Study   A comparative clinical study on the combined effect of Ashtachurna and Kushmanda Rasayana in children with mild to moderate malnutrition 
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 Suneeta Tammanni Bandigani 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College and Hospital  
Address  Kumarabhritya OPD no 11 JSS Ayurveda Medical College and Hospital 41E Lalitadripura Road Alanahalli Mysuru Mysore KARNATAKA 570082 India

Mysore
KARNATAKA
570082
India 
Phone  8105009525  
Fax    
Email  suneetabandigani9525@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyothy K B  
Designation  Professor 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Kumarabhritya OPD no 11 JSS Ayurveda Medical College and Hospital 41E Lalitadripura Road Alanahalli Mysuru Mysore KARNATAKA 570082 India

Mysore
KARNATAKA
570082
India 
Phone  7776014076  
Fax    
Email  jyothybmenon@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suneeta Tammanni Bandigani 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  Kumarabhritya OPD no 11 JSS Ayurveda Medical College and Hospital 41E Lalitadripura Road Alanahalli Mysuru

Mysore
KARNATAKA
570082
India 
Phone  8105009525  
Fax    
Email  suneetabandigani9525@gmail.com  
 
Source of Monetary or Material Support  
Kumarabhritya OPD no 11 JSS Ayurveda Medical College and Hospital 41E Lalitadripura Road Alanahalli Mysuru Mysore KARNATAKA 570082 India 
 
Primary Sponsor  
Name  Self 
Address  JSS Ayurveda Medical College and Hospital Kumarabhritya OPD no 11 41E Lalitadripura Road Alanahalli Mysuru 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suneeta Tammanni Bandigani  JSS Ayurveda Hospital  Kumarabhritya OPD no 11 41EJSS Ayurveda Medical College and Hospital 41E Lalitadripura Road Alanahalli Mysuru
Mysore
KARNATAKA 
08105009525

suneetabandigani9525@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Clearence Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K909||Intestinal malabsorption, unspecified. Ayurveda Condition: KARSYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kushmanda Rasayana, Reference: Baishajya Ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Ashta Churna, Reference: Astanga Hrudaya, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Kushmanda Rasayana, Reference: Baishaiya Ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: -
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1)Subjects aged between 3 to 12 years of age, irrespective of gender, religion and socio-economic status.
2)Subjects who fulfill the assessment criteria of mild to moderate Malnutrition as per IAP (Grade I & II)
3)Subjects whose parents/guardian are willing to give the informed assent.
 
 
ExclusionCriteria 
Details  1. Subjects with congenital and genetic abnormalities which interferes with nutritional status of the child.
2. Known cases of any systemic and infectious disorders necessitating continuous medications.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Astachurna and Kushmanda rasayana on clinical features, weight, chest circumference, mid arm circumference, mid-thigh circumference, BMI and skin fold thickness in children with mild to moderate malnutrition.
 
0th day
4th week
8th week
12th week 
 
Secondary Outcome  
Outcome  TimePoints 
1 To evaluate the efficacy of Kushmanda Rasayana on clinical features, weight, chest circumference, mid arm circumference, mid-thigh circumference, BMI and skin fold thickness in children with mild to moderate malnutrition.
2 To evaluate the efficacy of astachurna and Kushmanda Rasayana on clinical features, weight, chest circumference, mid arm circumference, mid-thigh circumference, BMI and skin fold thickness in children with mild to moderate malnutrition.
 
0th day
4th week
8th week
12th week post intervention 
 
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 2/ Phase 3 
Date of First Enrollment (India)   25/04/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

                            Malnutrition is a general umbrella term which addresses 3 broad groups like undernutrition, micronutrient related malnutrition and overweight. The term malnutrition addresses undernutrition, which includes wasting (low weight-for-height), stunting (low height-for-age) and underweight (low weight-for-age), Undernutrition impairs the immune function, which leads to growth retardation and impaired psychosocial and cognitive development in children.According to National Family Health Survey -5 (NFHS-5) carried out in 2019 – 2021, 35.5% and 19.3 % India’s children under 5 years are stunted and wasted respectively. 32.1% children under 5 years are underweight in India. In Karnataka, 11% and 5% children are malnourished and acutely malnourished.                              

Undernutrition in contemporary science resembles the clinical features of Karshya, in Ayurveda. Intake of faulty food habits like fast foods and nutrient poor foods like pizzas, burgers, carbonated drinks and chocolates  which are commonly found in children. Clinical manifestation of Karshya are presence of Shushka Sphik, Udara and Greeva (emaciation of buttocks, abdomen and neck), Dhamanijala santata (Prominent venous network in the body), Twagasthishisha (remained with skin and bones), Sthoola parva (prominent inter-phalangeal joints).Karshya is vata pradhana vyadhi , so Brihmana is a choice of treatment which gives Bala, Pushti and reduces Ruksha Guna of Vata. But when Agni is not good, Brimhana will not be effective as it affects digestion and absorption majorly. So the study hoypthesis that giving carmonative poly herbal drug along with nutritional supplement is more effective than giving nutritional supplement.

 
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