FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/01/079566 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study
Modification(s)  
Effect of adding an oral concentrated liquid protein source to dietary counselling in patients with Chronic Obstructive Pulmonary Disease (COPD)  
Scientific Title of Study   Comparing nutrient intake, functional capacity and quality of life in adults with COPD, given either an oral nutritional protein supplement with dietary counselling or receiving dietary counselling alone 
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 J Mohanakrishnan 
Designation  Consultant, Pulmonology & Sleep specialist 
Affiliation  Apollo Speciality Hospitals Ayanambakkam Chennai  
Address  07, Cardiac OPD, 1st Floor, Annex building, Apollo Speciality Hospitals, No. 64, Off P.H. Road, Vanagaram to Ambattur main road, Ayanambakkam, Chennai - 600095

Chennai
TAMIL NADU
600095
India 
Phone  9941156479  
Fax    
Email  drmkpulmo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr J Mohanakrishnan 
Designation  Consultant, Pulmonology & Sleep specialist 
Affiliation  Apollo Speciality Hospitals Ayanambakkam Chennai  
Address  07, Cardiac OPD, 1st Floor, Annex building, Apollo Speciality Hospitals, No. 64, Off P.H. Road, Vanagaram to Ambattur main road, Ayanambakkam, Chennai - 600095


TAMIL NADU
600095
India 
Phone  9941156479  
Fax    
Email  drmkpulmo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr J Mohanakrishnan 
Designation  Consultant, Pulmonology & Sleep specialist 
Affiliation  Apollo Speciality Hospitals Ayanambakkam Chennai  
Address  07, Cardiac OPD, 1st Floor, Annex building, Apollo Speciality Hospitals, No. 64, Off P.H. Road, Vanagaram to Ambattur main road, Ayanambakkam, Chennai - 600095


TAMIL NADU
600095
India 
Phone  9941156479  
Fax    
Email  drmkpulmo@gmail.com  
 
Source of Monetary or Material Support  
Dutch Medical Foods Door no 12/29 Plot no 14/1B Ranjith Road, Kotturpuram Chennai 600085 
 
Primary Sponsor  
Name  Dutch Medical Food 
Address  Door no 12/29 Plot no 14/1B Ranjith Road, Kotturpuram Chennai600085 
Type of Sponsor  Other [Neutraceuticals] 
 
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 J Mohanakrishnan   Apollo Speciality Hospitals   07, Cardiac OPD, 1st Floor, Annex building, Apollo Speciality Hospitals, No. 64, Off P.H. Road, Vanagaram to Ambattur main road, Ayanambakkam, Chennai - 600095
Chennai
TAMIL NADU 
9941156479

drmkpulmo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Biomedical Research, Apollo Hospitals, Chennai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dietary counselling  Dietary counselling Duration 90 Days 
Intervention  Protimedic an Oral Nutritional supplement and Dietary counselling   Dose: Two 10g protein in 20ml Sachets Dosage form: liquid form Frequency: Twice a Day bid Duration: 90 Days  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. COPD stage 2, stage 3, stage 4
2. Medium to high degree of malnourishment according to MUST.
3. Subject must be able to eat and drink.
4. Subject must be free living.
5. Subject must be able to provide informed consent.
 
 
ExclusionCriteria 
Details  1. Subjects with Liver, Heart or Kidney failure.
2. Subjects with Malignancy
3. Subjects with fever or pulmonary disease in addition to COPD.
4. Subjects with dysphagia
5. Subjects with poorly controlled diabetes.
6. Subjects with any disease state resulting in abnormal (high) A/G ratio.
7. Subjects receiving end of life care.
8. Subjects with known allergies to Milk and Collagen.
9. Subjects who are unable to provide informed consent.
10. Subjects with already taking health supplements
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of an oral nutritional supplement ONS taken with dietary counseling vs dietary counseling among COPD patients
1.Protein consumption
 
Day 0, Day 1, Day 28, Day 56. Day 84
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effects of an oral nutritional supplement (ONS) taken with dietary counseling vs. dietary counseling among COPD patients
1. Energy Consumption
2. Total food intake
3. Serum Total Protein
4. Serum Albumin: Globulin (A/G) ratio
5. Quality of life
6. Change in BMI
7. Change in Body weight
8. Hand grip strength will be assessed using a dynamometer at baseline and the end of the study
9. Distance walked 6 mins (or 12 mins) at baseline and the end of the study.
 
Day 0, Day 1, Day 28, Day 56, Day 84 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/02/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Almost 90% of COPD deaths occur in low- and middle-income countries, where effective strategies for prevention and control are not always implemented or accessible. Several key aspects of managing nutritional complications in COPD must be addressed, from assessing nutritional needs to implementing dietary strategies. Regular assessment of weight, BMI, and dietary intake is crucial for identifying and addressing nutritional issues early. This study will explore and inform the development of appropriate nutrition intervention strategies to improve the nutritional status, functional capacity, and thus QoL of patients with COPD. The primary objective is to compare the effects of an oral nutritional supplement (ONS) taken with dietary counseling vs. dietary counseling alone on Protein consumption. The secondary objective is to to compare the effects of an oral nutritional supplement (ONS) taken with dietary counseling vs. dietary counseling alone on Energy Consumption, Total food intake, Serum Total Protein, Serum Albumin: Globulin (A/G) ratio, Quality of life, Change in BMI, Change in Body weight, Hand grip strength will be assessed using a dynamometer at baseline and the end of the study and Distance walked 6 mins (or 12 mins) at baseline and the end of the study. PI Max and PE Max will be measured to assess lung function and will be recorded using spirometry. The Energy, protein intake will be assessed at baseline, weeks 4, 8 and 12 using a food diary distributed by study personnel Blood drawn at baseline and at the end of the study will be used to assess serum protein and ratio of serum albumin to globulin. Quality of life and COPD severity will be assessed at baseline, weeks 4, 8 and 12 using SF-36questionnaire.Compliance will be calculated as the amount of ONS consumed in proportion to prescribed calories and Safety will be assessed at baseline and at each visit until the end of the study.

 
Close