| CTRI Number |
CTRI/2013/01/003327 [Registered on: 28/01/2013] Trial Registered Retrospectively |
| Last Modified On: |
06/01/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders |
|
Scientific Title of Study
|
SPLASH : Survey of prevalence of Loss of Appetite in Subject with health disorders |
| Trial Acronym |
SPLASH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NN1213IN/Version 0.5/16 Nov 2011 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Rathod |
| Designation |
Senior Medical Advisor |
| Affiliation |
Bayer Zydus Pharma |
| Address |
Bayer India
Bayer Zydus Pharma
Kolshet Road
Thane - 400607
Mumbai
MAHARASHTRA
400607
India |
| Phone |
|
| Fax |
|
| Email |
rahul.rathod@bayerzyduspharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Rathod |
| Designation |
Senior Medical Advisor |
| Affiliation |
Bayer Zydus Pharma |
| Address |
Bayer India
Bayer Zydus Pharma
Kolshet Road
Thane - 400607
Osmanabad
MAHARASHTRA
400607
India |
| Phone |
|
| Fax |
|
| Email |
rahul.rathod@bayerzyduspharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Rathod |
| Designation |
Senior Medical Advisor |
| Affiliation |
Bayer Zydus Pharma |
| Address |
Bayer India
Bayer Zydus Pharma
Kolshet Road
Thane - 400607
Osmanabad
MAHARASHTRA
400607
India |
| Phone |
|
| Fax |
|
| Email |
rahul.rathod@bayerzyduspharma.com |
|
|
Source of Monetary or Material Support
|
| Bayer Zydus Pharma Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Bayer Zydus Pharma Pvt Ltd |
| Address |
Bayer India
Bayer Zydus Pharma Pvt Ltd
Kolshet Road
Thane |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrKailash Chandra Kapoor |
Dr.Kailash Chandra Kapoor |
E-92-93, Pandav Nagar, Samas Pur Road, Delhi- 110091
North
DELHI |
09350009265
anukapoor@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM, SUSHRUTAâ€, #1/1, 1st Temple Road, 15th Cross, Malleswaram, Bangalore 560 003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Malaria
Typhoid
Hepatitis
Acute infections - respiratory, urinary tract infections etc treated with antibiotics
-Tuberculosis
-general surgical procedures like acute appendectomy.
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Men and Non-pregnant women ≥ 18 years of age recuperating from healthcare disorders like:Malaria fever, Typhoid or enteric fever
Hepatitis
Acute infections including respiratory, urinary tract infections etc treated with antibiotic
Tuberculosis
Patient discharged from hospital after general surgical procedures like acute appendectomy, etc.
Any other condition
|
|
| ExclusionCriteria |
| Details |
Patients unwilling to provide informed consent & comply with the study procedure
Patient using drugs which affect appetite like Cyproheptadine etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients with loss of appetite. |
1 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients with fatigue. |
1 Day |
| Distribution of fatigue among the patients with respect to disease. |
1 Day |
Percentage of patients with moderate to very severe fatigue.
|
1 Day |
|
|
Target Sample Size
|
Total Sample Size="17500"
Sample Size from India="17500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/05/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is an epidemiological survey to find out the incidence of loss of appetite in Indian patients suffering from various health disorders. This survey will be conducted to obtain information on appetite from a total of 17500 subjects This study does not intend to study the effect of any drugs. The primary source of information will be the subjects themselves. The study will be conducted at 275 - 350 centres spread across India.This is a single visit study.The physician will conduct routine clinical, physical and general examination.
| 1 |
Dr.NAVEEN
CHHATWAL |
R 21 K 15 INDRA
PARK |
DELHI |
| 2 |
Dr.ASHOK PANSARI |
9,CHAHDERLOK
PITAMPURA |
DELHI |
| 3 |
Dr.S.P SETH |
134,MAIN ROAD OPP LSR |
NEW DELHI |
| 4 |
Dr.RAJEEV GUPTA |
KARUNA HOSPITAL D-62, |
DELHI |
| 5 |
Dr.SANJEEV SAGAR |
15-B.N.D.M.C MARKET |
DELHI |
| 6 |
Dr.MAHENDRA VERMA |
B-61,INDRA GANDHI
MARG |
DELHI |
| 7 |
Dr.DHARAM VEER ARORA |
S.D COLLEGE ROAD |
JALANDAR |
| 8 |
Dr. Rajiv Singh |
Kachcha Katra,
Shahjahapur, U.P-242001 |
U.P |
| 9 |
Dr.A.K.Gupta |
Dr.Tufail Ahmed Road,
Narahi, Lucknow- 226001 |
Lucknow |
| 10 |
Dr.S.P.Srivastav |
Vivekanand-3,
Lucknow- 226010 |
Lucknow |
| 11 |
Dr.S.VARADHARAJAN |
RAJAAH HOSPITAL GANDHI |
COIMBATORE |
| 12 |
Dr.PM NANJUDAPPAN |
72,RAMCHANDRA ROAD |
COIMBATORE |
| 13 |
Dr.D RANI |
KALPANA THEATRE ROAD |
COIMBATORE |
| 14 |
Dr.S.PRABHU VENKATESH |
NO 60,60-1 POLLACHI
ROAD |
DHARAPURAM |
| 15 |
Dr.A.DHANALAKSHMI |
RANGASAMUDRAM |
SATHYAMANGALAM |
| 16 |
Dr.P.ARULKUMAR |
ANNUR ROAD |
COIMBATORE |
| 17 |
Dr.MOHAMMED MUZAFFAR
SHARIF |
AMBERPET |
HYDERABAD |
| 18 |
Dr.M VIJAYAMOHAN |
OSMANIA MEDICAL
COLLEGE |
HYDERABAD |
| 19 |
Dr.A.v.v.Satyavarayana |
YAKHATPURA |
HYDERABAD |
| 20 |
Dr.JAWAD FAROOQUI |
PUMAPOO,KARWAR ROAD |
HYDERABAD |
| 21 |
Dr.K.VENKAT RAO |
PUNJAGUTTA |
HYDERABAD |
| 22 |
Dr.F.A QURESHI |
S.V COLONY RD 4 |
HYDERABAD |
| 23 |
Dr. S.VIDYASAGAR
REDDY |
BHAVANINAGAR |
HYDERABAD |
| 24 |
Dr.M VISWESWARA RAO |
LOTHUKUNTA MAIN ROAD |
SECUNDERABAD |
| 25 |
Dr.V R S MURTHY |
S.R NAGAR |
HYDERABAD |
| 26 |
Dr.DULAL
RADHAKRISHNAN |
NAWABPEN MAIN STREET |
NELLORE |
| 27 |
Dr.K THIRUPAL REDDY |
JOHARAPURAM ROAD |
KURNOOL |
| 28 |
Dr.B SHASHIDHAR |
KAUADIGUDA |
HYDERABAD |
| 29 |
Dr.CH.NAGABHUSHANA
RAO |
SHAREEN NAGAR |
KURNOOL |
| 30 |
Dr. SOUREN MISHRA |
ANANDA BAZAR MORE
STATION ROAD |
MALDA |
| 31 |
Dr. SUBRATA HALDAR |
CHAKIR MORE |
COOCHBEHAR |
| 32 |
Dr.MADHUSUDAN REDDY |
HANAMKANDA |
WARANGAL |
| 33 |
Dr.NARENDER KATAKAM |
NEAR GOPALSWAMY
TEMPLE,M.G ROAD |
WARANGAL |
| 34 |
Dr.ANAND BHOKRAY |
MAIN ROAD KAREEMABAD |
WARANGAL |
| 35 |
Dr.KAGPA REDDY |
HANAMKANDA |
WARANGAL |
| 36 |
Dr.SUMAN |
RD NO1,KAKAJI
COLONY,HANAMKANDA |
WARANGAL |
| 37 |
Dr.J RAVIKUMAR |
BESIDE
HNKI-DEPOT,KAKAJI COLONNY |
HANUMAKONDA |
| 38 |
Dr.M RAJESHWARAIAH |
GANDHICHOWK |
JAMMIKUNTA |
| 39 |
Dr.P NAGALINGAM |
NEW ROAD |
HUZURABAD |
| 40 |
Dr.VIGNANA CHARY |
MANKAMMATHOTA |
KARIMNAGAR |
| 41 |
Dr.V SESHAGIRI RAO |
NAKKA STREET,5KLM |
SRIKAKULAM |
| 42 |
Dr.G PRAKASH RAO |
DONDURU ROAD |
SRIKAKULAM |
| 43 |
Dr.M.G MANOZ |
DAY AND NIGHT
JUNCTION |
SRIKAKULAM |
| 44 |
Dr.T VENUGOPAL |
NEW BRIDGE ROAD |
SRIKAKULAM |
| 45 |
Dr.P B KRISHNAMURTHY |
KHAKELWADI |
NIZAMABAD |
| 46 |
Dr.HANUMAIAH BODEPUDI |
ADUSUMILLIVARI STREET
OPP PWD GRND |
VIJAYAWADA |
| 47 |
Dr.S RANGA RAO |
NALLAGATE
CENTRE,KRISHWALANKA |
VIJAYAWADA |
| 48 |
Dr.T V D SASI SEKHAR |
HALLIKHARJUNA RAO
STREET,HANUMANLU |
VIJAYAWADA |
| 49 |
Dr.S BALA
SUBRAHMANYAM |
OPP NIRMALA CONVENT
TONIA TOWERS |
VIJAYAWADA |
| 50 |
Dr. SUMANA BARUA |
SEVOKE ROAD |
SILIGURI |
| 51 |
Dr. AMAL SAIKIA |
NH 52 RD |
BISWANATH |
| 52 |
Dr.ANTHONY JOSEPH
JOHNSON |
195,GST ROAD |
CHENNAI |
| 53 |
Dr.SHYAMALA MUKUNDAN |
MEENAKSHIAMMA
MEMORIAL HOSPITAL |
PARYYANUR |
| 54 |
Dr. PINAKI RAJ KATILA |
NEAR BORNAMGHAR,
KUMARGAON |
TEZPUR |
| 55 |
Dr.ANIMESH DAS |
DAKSHIN PARA VILLAGE
GARULIA |
GARULIA |
| 56 |
Dr.ASIS MAITRA |
7/D BIJOY NAGAR |
NAIHATI |
| 57 |
Dr.DEBASIS
CHATTOPADHYAY |
BOXI BAGAN,DAKSHIN
PALLI,PO RAHARA |
PARGANAS |
| 58 |
Dr.Dibjyoti Biswas |
Swapnadeep, B-4/409,
Kalyani Nadia |
West Bengal |
| 59 |
Dr.NIKHIL RANJAN RAI |
SHEFALI MEDICAL
CLINIC RABINDRA PALLY |
KOLKATA |
| 60 |
Dr.S.K BISWAS |
3A BUSSTAND THAKARPUKUR DIAMOND |
KOLKATA |
| 61 |
Dr.DIBYENDU HALDAR |
COLUMBIA ASIA HOSPITAL SALT
LAKE |
KOLKATA |
| 62 |
Dr.RAJIV VARMA |
114,RABINDRA SAHANI
VARMA CLINIC |
KOLKATA |
| 63 |
Dr.CHANDI CHARAN PAN |
SURJA SEN STREET |
KOLKATTA |
| 64 |
Dr.SUBHASHCHANDRA
SATPATHY |
123ARASH BEHANI
AVENUE |
KOLKATA |
| 65 |
Dr.ISHTEYAQ AHMED |
22B,TOPSIA 2ND LANE |
KOLKATA |
| 66 |
Dr.TANVEER ALAM
ANSARI |
SHAFA CLINIC 84,D.B
ROAD (W) |
KOLKATA |
| 67 |
Dr.JOYDEEP BHOWNIK |
GE-19RABINDRAPALLY
BAGUIATI |
KOLKATA |
| 68 |
Dr.SUMALAYKAR |
M.M GHOSH ROAD |
KOLKATA |
| 69 |
Dr.AJOY BHASKAR
TEWARI |
BARPETA ROAD |
ASSAM |
| 70 |
Dr.HARAJAGINDRA SINGH |
ABHAYAPURI |
ASSAM |
| 71 |
Dr.SURAJIT SARMA |
BAZAR
ROAD |
KAWAIMAN |
| 72 |
Dr.KAMAL CHANDRA
GOGOI |
HOSPITAL ROAD |
DOLOKA |
| 73 |
Dr.KAMAL SARMA |
MR KAMARKUCHI PHC |
NALBARI |
| 74 |
Dr.BASANTA KR.DEKA |
BAHJANI HOSPITAL |
NALBARI |
| 75 |
Dr.RAMEN KUMAR KAKATI |
NA |
TAMALPUR |
| 76 |
Dr.PRADEEP KUMAR
SHARMA |
RANGAGARA ROAD,
Tinsukia |
ASSAM |
| 77 |
Dr.ARUN CHANDRA GOGOI |
CHOKIDINGEE |
DIBRUGARH |
| 78 |
Dr.BISWAJIT BARVAH |
MULAGABHARV PATH |
DIBRUGARH |
| 79 |
Dr.MINTU KR GOGOI |
JAIL ROAD NEAR RAILWAY CROSSING |
JORHAT |
| 80 |
Dr.KUSHAL DAS |
MISSON PATTY,WARD NO
9 |
GULAGHAT |
| 81 |
Dr.KUNDAN KUMAR |
J-41,INDRANAGAR
COLONY,VARANASI |
VARANASI |
| 82 |
Dr.ASHOK KUMAR
AGRAWAL |
ARYA NAGAR |
GORAKHPUR |
| 83 |
Dr.S.B SINGH |
HUKULGANJ,VARANASI |
VARANASI |
| 84 |
Dr.ANURAG RAI |
JALKAL ROAD |
DEORIA |
| 85 |
Dr.B.P Singh |
MACHALI SAHAR PANDAV |
jaunpur |
| 86 |
Dr.ASHOK KUMAR RAI |
HADHAVA
FATAK,BASHARATPUR ROAD |
GORAKHPUR |
| 87 |
Dr.SUMIT BANERJEE |
CHANDRAHATI ,BURWAN |
SREERAMPUR |
| 88 |
Dr.MOHAMMAD
SHAMSUDDIN MOLLA |
70/2/1,SRINIKETAN RD
BOLPUR,BIRBHUM |
SREERAMPUR |
| 89 |
Dr.ANABIL DUTTA |
|
CHAKDIGHI |
| 90 |
Dr.BASUDEB MUKHERJEE |
EAR FORTIS
HOSPITAL,CHANDANNAGAR |
CHANDAN NAGAR |
| 91 |
Dr.SUPRIYA PAL |
237,D.J
ROAD,HINDMOTOR HOOGTHY |
HINDMOTOR |
| 92 |
Dr.CHITTARANJAN GHOSH |
NEW
DANGALPARA,SURI,BIRBHUM |
SURI |
| 93 |
Dr.M.P.KHATRI |
MAHAVIR
NAGAR,JAWAIBANDH ROAD |
SUMERPUR |
| 94 |
Dr.PRITHVI SINGH
CHOUDHARY |
BANAR ROAD |
JODHPUR |
| 95 |
Dr.DAYAL SHARMA |
|
BIKANER |
| 96 |
Dr.PRAVEEN MAKKAR |
8C-2 JAWAHAR
NAGAR,SRIGANGANAGAR |
SRIGANGANAGAR |
| 97 |
Dr.BHOPAL SINGH BOMB |
MADHUBAN ROAD |
UDAIPUR |
| 98 |
Dr.SANDEEP SHAH |
OPP SARDAR BHAVAN |
VADODARA |
| 99 |
Dr.SHAIVAL TRIVEDI |
SANTOOR PARK,MAKARAND
DESAI MARG |
VADODARA |
| 100 |
Dr.ASHISH B MAKADIA |
BHUJ KUTCH |
BHUJ |
| 101 |
Dr.PUJARA NISHANT
KANTILAL |
HOSPITAL ROAD |
BHUJ |
| 102 |
Dr.PARESH OZA |
GOTHAMAN ROAD |
PALAMPUR |
| 103 |
Dr.VIREN BARAI |
OPP.S.T
STAND,VIRAMGAM |
AHEMEDABAD |
| 104 |
Dr.JITENDRA BHOGILAL
PATEL |
SARDAR
PATEL,NARAMPURA |
AHEMEDABAD |
| 105 |
Dr.NIRML PARMAR |
IOC ROAD CHADKHEDA |
AHEMEDABAD |
| 106 |
Dr.K.D TIBREWALA |
OPP.LALBANGLO C.G
ROAD |
AHEMEDABAD |
| 107 |
Dr.HARDIK S PATEL |
ISCRIPUR BUS STAND |
AHEMEDABAD |
| 108 |
Dr.VIMAL PATEL |
HATKESHWAR CIRCLE |
AHEMEDABAD |
| 109 |
Dr.RAJESH R YADAV |
SARDAR NAGAR |
AHEMEDABAD |
| 110 |
Dr.PRAFULLA PANDIT |
BALRAJ MARG DHANTOLI |
NAGPUR |
| 111 |
Dr.KIRAN AGARWAL |
AGRASEN WARD,AGRASEN
CHOWK |
AMBIKAPUR |
| 112 |
Dr.N P SHARMA |
PURANA POST OFFICE
ROAD |
AMBIKAPUR |
| 113 |
Dr.KAISAR SALEEM |
INDRAVATI COLONY ROAD |
RAIPUR |
| 114 |
Dr. SUBHANKAR DAS |
RAJAJALAB ROAD |
BILASPUR |
| 115 |
Dr.ASHOK KUMAR
PALIWAL |
LINK ROAD |
JANJGIR |
| 116 |
Dr.A.K TIRKEY |
SAWARIYA PARISHAR |
RAIGARH |
| 117 |
Dr.R.L AGARWAL |
GAUSHALA ROAD, |
RAIGARH |
| 118 |
Dr.P.K GUPTA |
NEAR GURUNANIK SCHOOL |
RAIGARH |
| 119 |
Dr.PRADEEP JAIN |
|
BALOD |
| 120 |
Dr.R.S NAIK |
ARYANAGAR |
DURG |
| 121 |
Dr.ATUL KUMAR AGARWAL |
|
DURG |
| 122 |
Dr.JOSHI MAYURESH |
152 MCCH SOC |
MUMBAI |
| 123 |
Dr.RAJESH R YADAV |
JANU COMPOUND |
MUMBAI |
| 124 |
Dr.CHETAN ANAND V
SHINDE |
CAESAR RD NEAR SAI
MANDIR ANDHERI |
MUMBAI |
| 125 |
Dr.RAJESH B GAIKWAD |
ARTHUR ROAD |
MUMBAI |
| 126 |
Dr.NAVRATNA SUNDESHA |
1ST PHANASWADI |
MUMBAI |
| 127 |
Dr.RAVINDRA GUPTA |
3RD ROAD KHAR W |
MUMBAI |
| 128 |
Dr.BHARATKUMAR V
PALAN |
147,MIDDLE CLASS
SOCIETY |
MUMBAI |
| 129 |
Dr.RAJESH MOHAN
KEWALRAMANI |
L.M ROAD |
MUMBAI |
| 130 |
Dr.ANOOP CHHAGANLAL
PATEL |
M.G ROAD,BORIVALI |
MUMBAI |
| 131 |
Dr.VILAS ANANT WADE |
|
MUMBAI |
| 132 |
Dr.RASIK M SHETIYA |
ALANDI ROAD |
PUNE |
| 133 |
Dr.RAJENDRA AGARWAL |
FOREST AREA |
SOLAPUR |
| 134 |
Dr.RAVINDRA R SALVE |
SANT SEVALAL CHOWK |
PUNE |
| 135 |
Dr.Anil Panse |
Health Clinic, Opp.
Octroi Naka, Katraj, Pune - 411046 |
PUNE |
| 136 |
Dr.ROHIT V SINGH |
TULINJ
ROAD,NALLASOPARA |
THANE |
| 137 |
Dr.DILIP M RAUT |
MIRA VILLAGE |
THANE |
| 138 |
Dr.BALAKRISHNA
MANJUNATH NAYAK |
PAREL VILLAGE ROAD |
MUMBAI |
| 139 |
Dr.SURESH DADU BHOITE |
SHRI KRIPA |
THANE |
| 140 |
Dr.ANIL AVHAD |
SHREE GANESH NAGAR
CHS |
MUMBAI |
| 141 |
Dr.VASANT V CHANDRA |
JIVDAYA LANE
GHATKOPAR |
MUMBAI |
| 142 |
Dr.E.K AJITKUMAR |
D.K SANDU MARG
CHEMBUR |
MUMBAI |
| 143 |
Dr.RAJNIKANT B
SANGHVI |
3-C VAISAKHI CAMA
LANE GHATKOPAR |
MUMBAI |
| 144 |
Dr.ASHISH EKLAHARE |
GANDHAR
NAGAR,KHADAKPADA |
MUMBAI |
| 145 |
Dr.JAMBU JAIN |
HATT ROAD |
GUNA |
| 146 |
Dr.PRADEEP SONI |
BAISAL KHEDI |
BHOPAL |
| 147 |
Dr.CHENSUKH PATIDAR |
SHUKLA COLONY MAIN
ROAD |
MANDSAUR |
| 148 |
Dr.SHATURGHAN
PANJWANI |
ROOP RAM NAGAR |
INDORE |
| 149 |
Dr.NADIM FAROOQUI |
KHAHRANA 190
KHIZRABAD |
INDORE |
| 150 |
Dr. AMOD BORKAR |
KAMAT COMPLEX |
GOA |
| 151 |
Dr.URVI P.JOSHI |
KUNTE ROAD AMALNER |
JALGAON |
|