| CTRI Number |
CTRI/2025/01/078945 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study on effectiveness of Suvarnaprash versus Nutrileha in the management of Karshya (P.E.M.) in children of 2 year age |
|
Scientific Title of Study
|
A Comparative study on effcicacy of Suvarnaprash versus Nutrileha in the management of Karshya (SAM) in
13-24 months children : A RCT |
| Trial Acronym |
Nutrileha in SAM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renu Bharat Rathi |
| Designation |
Professor, Head, PhD Dept of Kaumarabhritya, MGACHRC, Salod |
| Affiliation |
MGACH RC DMIHER Wardha |
| Address |
Professor, PG Dept. Kaumarbhritya MGACHRC,Salod, Wardha
Professor, PG Dept. Kaumarbhritya MGACHRC,Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09011058302 |
| Fax |
|
| Email |
rbr.226@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renu Bharat Rathi |
| Designation |
Professor, Head, PhD Dept of Kaumarabhritya, MGACHRC, Salod |
| Affiliation |
MGACH RC DMIHER Wardha |
| Address |
Professor, PG Dept. Kaumarbhritya MGACHRC,Salod, Wardha
Professor, PG Dept. Kaumarbhritya MGACHRC,Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09011058302 |
| Fax |
|
| Email |
rbr.226@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renu Bharat Rathi |
| Designation |
Professor, Head, PhD Dept of Kaumarabhritya, MGACHRC, Salod |
| Affiliation |
MGACH RC DMIHER Wardha |
| Address |
Professor, PG Dept. Kaumarbhritya MGACHRC,Salod, Wardha
Professor, PG Dept. Kaumarbhritya MGACHRC,Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09011058302 |
| Fax |
|
| Email |
rbr.226@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College, Hospital & Research Centre, Salod (H),DMIHER Wardha, India.
|
|
|
Primary Sponsor
|
| Name |
Dr Renu B Rathi and DMIHER Wardha |
| Address |
Mahatma Gandhi Ayurveda College, Hospital & Research Centre, Salod (H), DMIHER Wardha, India.
|
| 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 Renu Rathi |
Mahatma Gandhi Ayurved College Hospital Salod and periphery of Wardha |
Department of Kaumarbhritya OPD, Mahatma Gandhi Ayurved College Hospital Salod and periphery of Wardha
Wardha
MAHARASHTRA |
9011058302
rbr.226@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Mahatma Gandhi Ayurveda College, Hospital & Research Centre, Salod (H), Wardha, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E440||Moderate protein-calorie malnutrition. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Nutrileha, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1.5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Swarnaprashana, Reference: Kashyapa samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1.5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
Toddlers from 13-24 months of age Suffering from karshya
Toddlers having low weight for height, BMI for age and children falling in grade 3 and 4 classification of PEM according to IAP |
|
| ExclusionCriteria |
| Details |
Infants below 12 months and toddlers above 2 yrs of age.
Toddlers suffering from infectious diseases like tuberculosis, HIV, etc
Diagnosed cases of Hyperthyroidism, malabsorption syndrome, congenital anomalies
Parents/ guardian who are not ready to give informed/ written consent for the study.
Toddlers suffering from complicated SAM
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of Nutri leha & Suvarnaprashan relief of the symptoms of Karshya(Severe Acute Malnutrition), on subjective and objective parameters and shifting of grades from SAM to MAM
|
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immunomodulation |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/01/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
ØIn Ayurveda, PEM (protein energy malnutrition) mentioned as Karshya,sukhandi, bal-shosh, kshaya etc. (malnutrition) is a disease in which to jatharagnimandya leading to dhatwagnimandya ultimately causing rasadidhatukshaya, the child becomes emaciated.Alpa bhojana (inadequate food intake), atirukshaannapana, parental negligence are the main causes of karshyaSuvarnaprash improves Intelligence, Digestive fire, physical power, rejuvenation, positivity and long life,Second trial drug Nutri Leha which contains Ashwagandha, Trikatu, ghrita, tilataila, madhu having qualities like rasayana, deepana, pachana, brumhana which can be beneficial in improving the condition of children suffering from Karshya. In developing countries like India , malnutrition in children is a challenging and significant public health problem in spite of implementing many nutritional policies to overcome it.Globally, 161 million children under five year age are suffering from malnutrition this condition is worse in developing countries like India with a prevalence rate of 48 %. Population- Toddlers from 13-24 months of age suffering from Karshya irrespective of religion, race, gender and socioeconomic condition. Intervention-Nutri Leha in a semisolid form – a leha preparation.Comparison-Swarnaprash, Outcome-Effect of Nutri leha & Suvarnaprashan relief of the symptoms of Karshya(Severe Acute Malnutrition), on subjective and objective parameters and shifting of grades from SAM to MAM. Time-90 days |