CTRI

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CTRI Number

CTRI/2019/05/018917 [Registered on: 03/05/2019] Trial Registered Prospectively

Last Modified On:

05/07/2019

Post Graduate Thesis

Type of Trial

PMS

Type of Study

Other (Specify) [Oral Nutritional Supplement]

Study Design

Single Arm Study

Public Title of Study

Benefits of Standard ONS in Indian Adults

Scientific Title of Study

An observational, multicenter study to evaluate the benefits of regular intake of standard ONS (ENSUREÂ®) in Indian Adults.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
DA18, Version1.0 dated 05-Mar-2018	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ganesh Kadhe
Designation	Associate Director
Affiliation	Abbott Healthcare Pvt. Ltd.
Address	Medical and Scientific Affairs, Abbott Healthcare Pvt Ltd., Floor 15th, Godrej BKC, Plot No. C - 68, BKC, Near MCA Club, Bandra (E) Mumbai MAHARASHTRA 400051 India
Phone	022-38161417
Fax
Email	ganesh.kadhe@abbott.com

Details of Contact Person
Scientific Query

Name	Dr Ganesh Kadhe
Designation	Associate Director
Affiliation	Abbott Healthcare Pvt. Ltd.
Address	Medical and Scientific Affairs, Abbott Healthcare Pvt Ltd., Floor 15th, Godrej BKC, Plot No. C - 68, BKC, Near MCA Club, Bandra (E) Mumbai MAHARASHTRA 400051 India
Phone	022-38161417
Fax
Email	ganesh.kadhe@abbott.com

Details of Contact Person
Public Query

Name	Dr Ganesh Kadhe
Designation	Associate Director
Affiliation	Abbott Healthcare Pvt. Ltd.
Address	Medical and Scientific Affairs, Abbott Healthcare Pvt Ltd., Floor 15th, Godrej BKC, Plot No. C - 68, BKC, Near MCA Club, Bandra (E) Mumbai MAHARASHTRA 400051 India
Phone	022-38161417
Fax
Email	ganesh.kadhe@abbott.com

Source of Monetary or Material Support

Abbott Healthcare Pvt. Ltd. Floor 15, Godrej BKC, Plot No. C â€“ 68, G Block, Near MCA Club, BKC, Bandra (E) Mumbai 400051

Primary Sponsor

Name	Abbott Healthcare Pvt Ltd
Address	Floor 15, Godrej BKC, Plot No. C â€“ 68, G Block, Near MCA Club, BKC, Bandra (E) Mumbai, 400051
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 71
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr V S Natarajan	Adhiparasakthi Clinic	No. 50 Flowers Road, Kilpauk, Chennai TAMIL NADU	9500078740 dr_v_s_natarajan@yahoo.com
Dr E K Ajit Kumar	Ajitkumar Clinic	Thank God Buildig, D. K. Sandu St, Mahadeo Wadi, Chembur Est., Mumbai Mumbai MAHARASHTRA	09820092773 dr.ek.ajit.kumar@gmail.com
Dr Praveen Bhanot	Bhanot Clinic	27/48 Gali No. 6, Vishwas Nagar, Shahdara, East DELHI	9810182618 drpraveenbhanot16@gmail.com
Dr Gopichand Bulchandani	Bhulchandani Hospital	Shop No. 4, Shreedutt Apartment, Amarsi Road, Malad West, Mumbai Mumbai MAHARASHTRA	9820867851 drbulchandani@yahoo.co.in
Dr Jaysh Boricha	Boricha Clinic	1, Laxmi Sadan, Telhi Naka, Eduji Road, Thane Thane MAHARASHTRA	9820324861 drboricha@rediffmail.com
Dr Vinod Chandi	Chandi Clinic	-16, Shiv Puri Extension, East DELHI	9811007972 vinodchandi2@gmail.com
Dr Kannan Natarajan	Chandra Chest and Diabetes Care Center	#50, Seven Wells Street, Chennai TAMIL NADU	9884067099 drnkanna@gmail.com
Dr Khushwanth Singh	City Clinic	H. No. 23 Kanti Shikara Apartment, Punjagutta Clinics, Punjagutta Hyderabad TELANGANA	9246529394 dr.khushwanth@gmail.com
Dr Akil Contractor	Contractor Clinic	Sai Aradhna, Firoz Shah street, Santacruz West, Mumbai Mumbai MAHARASHTRA	09892084360 raziakol@hotmail.com
Dr Mohammed Javed	Dass Medical Hall	#23, Mcleod Street, Elliot Road, Near Ghalib Bar, Kolkata WEST BENGAL	9883102325 drmdjaved3@gmail.com
Dr Y M Dave	Dave Cinic	Shop 24, Jawahar Nagar, S. V. Road, Goregaon West, Mumbai Mumbai MAHARASHTRA	9820100683 drymdave@gmail.com
Dr R K Kaushik	Dayal Nursing Home	Dayal Hospital and Maternity Centre, 57, Pck H/33, Sector 3, Rohini, North West DELHI	9810076227 drkaushikramakant@rediffmail.com
Dr Sudhir Devrukhakar	Devrukhakar Clinic	Shop No. 3, Om Shree Ganesh Society, Opposite Manish Nagar Gate 1, Kalwa Thane Thane MAHARASHTRA	9322834057 doctor.sudhir@hotmail.com
Dr K D Dabholkar	Dhabolkar Clinic	1/2 Sanket, Alka Nagar, Vakola Police Station, Mumbai MAHARASHTRA	9869086530 kddabholkar@yahoo.co.in
Dr Naresh Chawla	Dr Naresh Chawla Clinic	N 172-173 Raghubir Nagar, New Delhi DELHI	9811385711 drchawlanaresh@gmail.com
Dr A K Chatterjee	Dr. A. K. Chatterjee Clinic	A2/1, Kurunamoyee Housing Estate, Salt Lake, Sech Bhavan, Salt Lake, Kolkata WEST BENGAL	9830152907 asokekumarchatterjee38@gmail.com
Dr A Mahadev	Dr. A. Mahadev Clinic	4-5-261/3, Pan Bazaar, Secunderabad, Hyderabad TELANGANA	9247862449 dramahadev60@gmail.com
Dr Arabinda Halder	Dr. Arabinda Halder Clinic	134/2, DH Road, East Barisha Govt Colony, Thakurpukur, Kolkata WEST BENGAL	9433310500 dr.halderarabinda2@gmail.com
Dr Asoktaru Sengupta	Dr. Asoktaru Sengupta Clinic	24/7/1, Natabar Paul Road, Dasnagar, Howrah Kolkata WEST BENGAL	9830195724 Senasok2011@gmail.com
Dr Jagdish Singh	Dr. Jagdish Singh Clinic	H. No. 7-1-215, Balkampet, Hyderabad TELANGANA	9848051904 drjagsgh@gmail.com
Sunidhi Health Centre	Dr. Kumar U.	No.15,1st C Main Road, Shakthi Garden, Kalyan Nagar, Bangalore KARNATAKA	9742220084 kumarugrappa@yahoo.co.in
Dr Mridul Bera	Dr. Mridul Bera Clinic	21/2, Andul Road, Tetultala , Beside Onkar Channel Office, Kolkata WEST BENGAL	9830170613 mridulbera@rediffmail.com
Dr O P Sharma	Dr. O. P. Sharma Clinic	85D, Ghosh Para Road, Barrackpore, Dist - North Twentyfour Parganas, North Twentyfour Parganas WEST BENGAL	8420472233 dr.opsharma872@gmail.com
Dr Parinata Roy	Dr. Parinata Roy Clinic	41/37 Dum Dum Road, Kolkata WEST BENGAL	9830063137 royparinata@gmail.com
Dr Prakash B	Dr. Prakash B. Clinic	No. 221, Jaganatha Krupa, Paravathi Nagar, Laggere Main Road, Bangalore KARNATAKA	9972091947 drprakashbanappa@gmail.com
Dr Raj Gopal Kishan	Dr. Raj Gopal Kishan Clinic	91 RTC Colony, Trimulgherry, Secundrabad Hyderabad TELANGANA	9396707172 rajgopalkishan@gmail.com
Dr S Nagrajan	Dr. S. Nagrajan Clinic	2/98, IInd Main Road, Ragavanagar, Maddipakkam, Chennai TAMIL NADU	9841051949 eardnag@gmail.com
Dr Vikas Sharma	Dr. S. Vikas Clinic	RSC Rd Number 11, Jivdeep CHS, Sector 1 Charkop, Kandivali West, Mumbai, Maharashtra 400067 Mumbai MAHARASHTRA	9867650822 vikasphysician@yahoo.co.in
Dr Srinivasan M	Dr. Srinivasan Clinic	52, Mulla Sahib Street, George Town, Sowcarpet, Chennai TAMIL NADU	9444388969 drsrinivasanmunuswamy@gmail.com
Dr Sriram V	Dr. Sriram V. Clinic	52, Mulla Sahib Street, George Town, Sowcarpet, Chennai TAMIL NADU	9003111426 dr.sriram@live.com
Dr Suddhasatwa Ghosh	Dr. Suddhasatwa Ghosh Clinic	No.-2, Debigarh, Po: Madhyamgram, Kolkata WEST BENGAL	9836326188 70aparajita@gmail.com
Dr U V Mohan	Dr. U. V. Mohan Clinic	11/56, Appar Street, Gopal Nagar, Padi, Chennai TAMIL NADU	9444050026 urjanmohan@yahoo.com
DrVinay J	Dr. Vinay J. Clinic	#250, 1st Main, 1st Cross, Srigandhanagara, Hegganahalli Cross, Bangalore KARNATAKA	9740135014 drvinayjgowda@gmail.com
Dr Mukesh Kumar Sharma	Gayatri Clinic	Lalbazar Tirumalgiri, Secunderabad Hyderabad TELANGANA	9441017187 dr.mukeshsharma2@gmail.com
Dr Mohammed Asif Nijam	GD Hospital & Diabetes Institute	139 A, Lenin Sarani, Kolkata WEST BENGAL	9733254247 asif16278@gmail.com
Dr P Somulu	Geetha Hospital	H. No. 1-7-90, Chaitanyapuri, Hyderabad TELANGANA	9848042878 dr.soms@yahoo.c.in
Dr V K Goel	Goel Clinic	4/ 7012, Rama Block, Bhola Nath Nagar, Shahdara, New Delhi DELHI	9868525757 drvinodkgoel@gmail.com
Dr Mary DCruz	Healthy Lifestyle Clinic, Kolkata	42, Ananda Palit Road, Kolkata WEST BENGAL	9051517771 drmary91@gmail.com
Dr Suresh Hegde	Hegde Multi Speciality Clinic	1032, 26th Main, 4th Block, Jayanagar, Bangalore KARNATAKA	9845519950 drsureshhegde3@gmail.com
Dr R L Nagrani	Jai Hospital	Jai Clinic, 993, Gurudwara Road, Rani Bagh, North West DELHI	9811077538 nagranirattan@gmail.com
Dr Ravi Jain	Jain Clinic	399-B, Pocket II, Mayur Vihar Phase I East DELHI	9810094498 ravijain397b@gmail.com
Dr Sriganga S	Javantika Clinic	2/3, Javantika Clinic, Mandhavelipakkam, Chennai TAMIL NADU	9840814978 srigangagopal@gmail.com
Dr Anirudh Lochan	Jeevan Jyoti Nursing Home	Jeevan Jyoti Clinic and Hospital, GTB Chowk, Dilshad Garden, North East DELHI	9891287076 jjhdilshad@rediffmail.com
Dr J Joshi	Joshi Clinic	H-4/1 Krishna Nagar, East DELHI	9810568996 dr.joshi@rediffmail.com
Dr Vinod Khetrapal	Khetrapal Clinic	Khetrapal Nursing Home, GN 5, Shivaji Enclave, Near Shivaji College, New Delhi DELHI	9811054945 vkhetarpal@gmail.com
Dr Vijay Krishnan	Krishnan Clinic	B21, Motinagar, New Delhi DELHI	9810038862 drvijaykrishan@yahoo.co.in
Dr Ashwani Malhotra	Malhotra Clinic	Malhotra Medical & Dental Care, D7 Tagore Garden Extension, New Delhi DELHI	9811137830 ashwani.malhotra419@gmail.com
Dr M N Lakshmikanth Reddy	Maxcure Hospitals	Behind Cyber Towers, Lane Next to MacDonaldâ€™s Hitech city, Madhapur, Hyderabad TELANGANA	9885162066 mnlkreddy@gmail.com
Dr Sougata Sanyal	Narayana Multispeciality Hospital	BB- 198, Salt Lake, Kolkata WEST BENGAL	9804269758 gurudutta10@gmail.com
Dr P C Pahwa	Pahwa Clinic	D 98, New Govind Pura, Parwana Road East DELHI	9811078442 pcpahwa@gmail.com
Dr Tarachand Pawar	Pawar Clinic	Room No. 79, Building 14, Suniti Co-op Society, Shivaji Nagar, Thane Thane MAHARASHTRA	9821442341 kavitara_kt@rediffmail.com
Dr K P Parthasarathy	Prime Family Medical Centre	39, Q Block, 6th Avenue, Anna Nagar, Chennai TAMIL NADU	9840604444 drkpps@gmail.com
Dr Naseem Qureshi	Qureshi Clinic	Natalwala Building, Veer Savarkar Marg, Mahim, Mumbai Mumbai MAHARASHTRA	09821110029 naseemqureshi1943@yahoo.com
Dr H S Rupoi	Rupoi Clinic	B-21, Bhagat Singh Road, New Govindpura East DELHI	7503911166 drhardeep.ruproi@yahoo.com
Dr Sanghamitra Raha	Salt Lake Clinic, Kolkata	2R-2/8, Phase-II Purbachal, Sector-III, Block-GA Salt Lake, Kolkata WEST BENGAL	9433080906 mrdrraha@gmail.com
Dr D K Sharma	Sanjeevan Clinic	90/3, East Guru Angad Nagar, New Delhi DELHI	9810071445 drdraunsharma@gmail.com
Dr D Vivekanatha Raj	Saraswathi Clinic	No. 757th Road, Thiruvottiyur, Chennai TAMIL NADU	9600014740 vivekam@doctor.com
Dr Prashant Seth	Seth Hospital	B2-15/16, Sector 16, Vashi, Navi Mumbai Mumbai MAHARASHTRA	9820958957 dr.prashantsheth13@gmail.com
Dr Surendra Shah	Shah Clinic	Dhanwantari Clinic, Sector 3, Opposite Abbott Hotel, Vashi, Navi Mumbai Mumbai MAHARASHTRA	9322590495 drsnshah6565@yahoo.com
Dr Yogesh H Shah	Shah Clinic	223, Ashirwad P Kheraj Road, Mulund, Mumbai Mumbai MAHARASHTRA	09833689332 shah9@rediffmail.com
Dr Vinod Kr Gautam	Sharma Clinic	Sharma Nursing Home, Yamuna Vihar, North East DELHI	9810368153 vinodgautam93@gmail.com
Dr Gautam Singh	Shri Ram Singh & Heart Institute	Shri Ram Singh and Heart Institute, 26, East Krishna Nagar, East DELHI	9899943833 gautam009@gmail.com
Dr Ashok Bammanakatti	Shri Sharada Multi Specialty Hospital	#48 Ramanashree Nagar, Doddakammanahalli Road, Bannerughatta Main Road, Bangalore KARNATAKA	9483464457 drsharadaashokb63@gmail.com
Dr Anita R Soans	Sons Clinic	NL/ 4/25/03, Sector 11, Nerul, Navi Mumbai Mumbai MAHARASHTRA	9820277602 anitasons227@gmail.com
Dr A K Sreedharan	Sow-Krish Clinic	11/1A, Ellaiamman Koil Street, 1st Avenue, Sastrinagar, Adayar Chennai TAMIL NADU	9884314781 doc_sree@yahoo.com
Dr N Parameswaran	Sree Narayana Nursing Home	2/98, IInd Main Road, Ragavanagar, Maddipakkam, Chennai TAMIL NADU	044-25514626 snnhealthcare@gmail.com
Dr Shantaveer M Budihal	Sri Sai Health Care Center	8th Cross, Hosa Road, C. K. Nagar, Electronic City, Bangalore KARNATAKA	9916726766 shantaveer363@gmail.com
Dr S Subramanyam	Subramanyams Day Care Center	137, 3rd Main, 9th Cross, Chamrajpet, Bangalore KARNATAKA	9845029954 subbusarof@yahoo.com
Dr Kamlesh Thakkar	Thakkar Clinic	4/5 Adarsh Nagar, Kolbad, Thane West, Mumbai Thane MAHARASHTRA	9324514986 kamleshthakkar08@gmail.com
Dr Aslam Yousuff	Vasavi Clinic	No. 10, Subramani Street, Purasaivakkam, Chennai TAMIL NADU	9840130844 aslamydr@gmail.com
Dr R Ganesh	Vcure Clinic	No. 98, Devi Karumariamman Nagar, Velachery Main Road, Chennai TAMIL NADU	044-22463304 vcuregs07@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Suraksha Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Poor Nutritional Status

Intervention / Comparator Agent

Type

Name

Details

Inclusion Criteria

Age From	45.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	1. Ambulatory adult patients >or equal to 45 years of age 2. Patients at the risk of malnutrition (MST > or equal to 2) 3. Patients who understand nature of the study, willing to participate in all scheduled visits and trial procedures & provide a written informed consent.

ExclusionCriteria

Details

1. Subject using commercially available macronutrient food supplements or another ONS
2. History or evidence of hypersensitivity to any component of study product
3. History of any Gastrointestinal disorder/surgery that affects digestion and/or absorption of food
4. Evidence of active TB, Hepatitis B, Hepatitis C or HIV infection, type 1 or type 2 diabetes mellitus, malignancy and any other disease affecting appetite and weight loss
5. History or evidence of any medical condition that in the opinion of Investigator can interfere with the study assessment of outcome or Patients with scheduled surgery during the duration of the study
6. Subjects who are unlikely to comply with the study protocol or follow up regularly for study assessments
7. Pregnant or lactating women

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Measured weight kg	Baseline to 12 weeks

Secondary Outcome

Outcome	TimePoints
Hand Grip- Dynamometer	Baseline to 12 weeks
Quality of Life: WHOQOL-BREF	Baseline to 12 weeks

Target Sample Size

Total Sample Size="1500"
Sample Size from India="1500"
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)

08/05/2019

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)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

None yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Different studies in India have shown that more than 50% of adult population of India are suffering from malnutrition and more than 90% have less than recommended intake. Nutritional status and handgrip strength improved significantly with ONS. In already malnourished subjects it may be too late to include improvement so prevention is key, so all elderly subjects need to be assessed and intervention initiated early. The current study has been designed as there is not sufficient Indian data available on the benefits of using ONS in patients. This is a prospective, single arm, baseline-controlled multicenter study to observe benefits on Oral Nutritional Supplement (ONS) intake in adults with medical conditions associated with poor nutritional status.