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CTRI Number  CTRI/2025/04/085183 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study of green gram laddu as nutraceutical among adolescent age group with low weight  
Scientific Title of Study   Analytical and clinical study of mudga modaka as nutraceutical in karshya among adolescent age group  
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 Jyothsna N G 
Designation  PG Scholar 
Affiliation  JSS Ayurveda medical college and hospital, Mysuru 
Address  JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9742537434  
Fax  08212548360  
Email  saijyothsnareddy24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr P Sudhakar Reddy 
Designation  Professor and Head 
Affiliation  JSS ayurveda medical college and hospital 
Address  Department of PG studies in Swasthavritta, OPD no.12, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9916483919  
Fax  08212548360  
Email  drpsreddy05@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr P Sudhakar Reddy 
Designation  Professor and Head 
Affiliation  JSS ayurveda medical college and hospital 
Address  Department of PG studies in Swasthavritta, OPD no.12, JSS Ayurveda medical college and hospital, Lalithadripura road, Mysuru


KARNATAKA
570028
India 
Phone  9916483919  
Fax  08212548360  
Email  drpsreddy05@yahoo.com  
 
Source of Monetary or Material Support  
JSS ayurveda medical college and hospital, Lalithadripura road, Mysuru, Karnataka, India, 570028 
 
Primary Sponsor  
Name  Dr Jyothsna N G 
Address  Department of PG studies in Swasthavritta, JSS ayurveda medical college and hospital, Lalithadripura road, Mysuru, Karnataka, India, 570028 
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 Jyothsna N G  JSS Ayurveda medical college and hospital, Mysuru  Room No.12, Department of PG studies in Swasthavritta, JSS ayurveda medical college and hospital, Lalithadripura road, Mysuru
Mysore
KARNATAKA 
9742537434

saijyothsnareddy24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS ayurveda medical college   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E440||Moderate protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Nil, Ritucarya: Nil, Acara Rasayana:Nil, Other:Mudga Modaka (15gms) twice a day along with the prescribed pathya., Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  Subjects with underweight having BMI less than or equal to 18.5 with any two Lakshanas of Karshya such as Sushka Spick , Sushka Udara , Sushka Greeva, Damani Jala Santata, Twag Asti Shosha, Stoola Parva
 
 
ExclusionCriteria 
Details  Subjects having BMI more than 18.5, Karshya due to any other disease.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase in BMI   4 week 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in serum protein value and Hb value  60 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   30/04/2025 
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="1"
Months="6"
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  

Need for the study:

Undernutrition is a set of conditions that result from inadequate consumption, poor accretion or excessive loss of nutrients.

Undernourished persons are described under Astaninditiya Purusha, Karshya is one among that.

According to worldometer USA India is the largest contributory of undernourished people in the world, among 8 billion people in the world 194,400,000 people of India are malnourished.

According to WHO adolescent age group is 10-19 years.

Proteins are needed by the body for body building, synthesis of certain substance like antibodies, plasma proteins, haemoglobin, enzymes, hormones and coagulation factor. Protein is connected with immune mechanism of the body.

For maximum utilization of dietary proteins, the calorie intake should be adequate. The body proteins are constantly being broken down into their constituent amino acids and then reused for protein synthesis. Since proteins are not stored in the human body in the way that energy is stored in adipose tissue, they have to be replaced every day.

Undernutrition is strongly associated with shorter adult height, poor lean weight, less schooling, low cognition, reduced economic productivity and, for women lower offspring, low birthweight and undernutrition in childhood are Important risk factors for diabetes mellitus, hypertension and dyslipidaemia in adulthood. According to Acharya Charaka Ahara is one among the Trayopasthamba. Ahara is causative factor for both development of body as well as diseases.

Mudga (Vigna radiata) is one among Nithya Sevaniya Ahara and it is Pustibalapradham. Because of its availability and widely used food article and which can be easily prepared as a Modaka at home and can be taken daily as a protein supplement to under nourished subjects to see its Balya effect.

Hence the present study is taken to find Balya effect in adolescent age group as Mudga Modaka in Karshya as a physical health promoter.

Review of literature:

Mudga (Vigna radiata) is Nithya Sevaniya Ahara.Mudga (Vigna radiata) is Pusti Balakritam.

Among all Simbhidhanya Varga, Mudga (Vigna radiata) is best.

Mudga modaka is bestows strength and nourishment

Nutritive values of Mudga (Vigna radiata) are documented by united state department of agriculture USDA. Nutraceuticals may be used to improve health, delay the aging process, prevent chronic diseases, increase life expectancy, or support the structure or function of the body. Nowadays, nutraceuticals have received considerable interest due to potential nutritional, safety and therapeutic effects.

Description of Karshya - Charaka Samhitha Sutra Sthana 21st chapter, Ashtanga Hrudaya Sutra Sthana 14th chapter, Sushrutha Samhita Sutra Sthana 14th chapter.

AIMS AND OBJECTIVES OF STUDY:

1. To study the nutritional value of the Mudga Modaka.

2. To evaluate the effect of Mudga Modaka in Karshya among adolescent age groups.

3. To study the effect of Mudga Modaka in variation of protein value and haemoglobin in Karshya among adolescent age group.

METHOD OF PREPARATION:

500 grams of Mudga (green gram) flour will be taken in a vessel,500ml of water will be added and will be made in to a batter form. 500 grams of cow’s ghee is heated in kadhai.

Mudga (green gram) batter is allowed to fall through a sieve into the heated ghee drop by drop, and this is cooked properly until pearly consistency, then it is taken out from the kadhai, and it will be shifted in to a sperate vessel.  

500 gram of sugar (sugar candy) will be taken in a kadhai, sufficient quantity of water will be added and Paka will be prepared of 1-2 thread consistency, to this Paka cooked pearly Mudga (green gram) Ela, Maricha/Shunti is added and mixed properly. 15grams of Modaka will be prepared and stored in an air tight container.

ASSESSMENT CRITERIA:

Subjective parameters will be assessed by grading the symptoms of Karshya.

Objective parameters

Serum estimation of Protein and Hb

Anthropometric measurements Weight

Height

BMI

Mid arm circumference

Chest circumference

Waist circumference

Hip circumference

Mid-thigh circumference

Mid-calf circumference

Skin fold thickness


 
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