| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K909||Intestinal malabsorption, unspecified. Ayurveda Condition: KARSYAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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. |