| CTRI Number |
CTRI/2025/04/085735 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to See Whether Krishnatila Modak or Protein Powder Helps Thin Adults Gain Healthy Weight |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to Evaluate the Efficacy of Krishnatila Modak in Karshya with Special Reference to Underweighted Adults |
| 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 Ajaykumar Krishnappa Pattar |
| Designation |
PhD Scholar |
| Affiliation |
Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Centre |
| Address |
Department of Swasthavritta
Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Centre, Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
09902741439 |
| Fax |
|
| Email |
ajaykumar.pattar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Bapusaheb Nakil |
| Designation |
Professor and Head of the Department |
| Affiliation |
Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Centre |
| Address |
Department of Swasthavritta
Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Centre, Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822287051 |
| Fax |
|
| Email |
rahul_nakil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajaykumar Krishnappa Pattar |
| Designation |
PhD Scholar |
| Affiliation |
Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Centre |
| Address |
Department of Swasthavritta
Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Centre, Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
09902741439 |
| Fax |
|
| Email |
ajaykumar.pattar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ajaykumar K. Pattar
Self-Funded Project, PhD Scholar
Department of Swasthavritta
Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Centre, Islampur Tal Walwa Dis sangli Maharashtra Pin 415409 India |
|
|
Primary Sponsor
|
| Name |
Dr Ajaykumar Krishnappa Pattar |
| Address |
PhD Scholar Department of Swasthavritta Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Centre, Islampur Tal Walwa Dis sangli Maharashtra Pin 415409 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 Ajaykumar Krishnappa Pattar |
Loknete Rajarambapu Patil Ayurvedic Hospital |
Department of Swasthavritta OPD Room no 4
Sangli
MAHARASHTRA |
09902741439
ajaykumar.pattar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional (Human) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krishnatila modak, Reference: Bhojankutuhalam, Route: Oral, Dosage Form: Modaka , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Normal water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Protein supplement | [It is a proprietary product of Netsurf Communication (P) Ltd, Pune, India. The product is
composed of plant-based proteins, milk solids, micronutrients like vitamins, minerals, probiotics
like Bifidobacterium, Lactobacillus together with some specialized natural ingredients like
Colostrum, Omega 3 DHA, Aloe Vera and Zeaxanthin etc |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
BMI ranges from 16 kg/m2
to 18.50 kg/m2
Signs and symptoms of Karshya according to Ayurveda classics and modern science.
|
|
| ExclusionCriteria |
| Details |
1. weight loss secondary to diseases like tuberculosis,chronic kidney diseases,etc
2. participants who are on prolong medications, pregnancy, lactation.
3. participants who have skin diseases and prediabetes, diabetic state.
4. Subjects with hemoglobin level below the 7gm/dl.
5. participants who have allergic to Krishna tila and protein supplement. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Krishnatila Modak in Increasing Weight Among Underweight Adults Diagnosed with Karshya |
First Month, Second Month, Third Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in Hemoglobin Levels Among Underweight Adults |
First Month, Second Month, Third Month |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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 3 |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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
|
Nutrition plays a crucial role in maintaining good health and well-being. A lack of essential nutrients can lead to undernutrition, with significant health implications. Various nutritional supplements, protein powders, and fortified foods are available to manage undernutrition, but these products have some limitations. Issues related to taste, smell, affordability, and the presence of chemical substances can make them less desirable. Ayurveda offers a traditional and natural solution to undernutrition called Tila Modak. The classical textbook Bhojankutuhalam5 explains that it is safe, effective, and contains no harmful chemicals. This suggests that exploring traditional and cultural sources for nutritional supplementation is important and can help meet individuals’ nutritional needs |