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CTRI Number  CTRI/2013/07/003818 [Registered on: 18/07/2013] Trial Registered Prospectively
Last Modified On: 08/07/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathy in Diabetic Neuropathy 
Scientific Title of Study   Efficacy of homoeopathic treatment for Diabetic Distal Symmetric Polyneuropathy: A multicentric randomized double blind placebo controlled clinical trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr RK Manchanda 
Designation  Director General 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy 61-65 Institutional Area Opp D Block Janakpuri New Delhi

South West
DELHI
110058
India 
Phone  28525523  
Fax  28521060  
Email  ccrh@del3.vsnl.net.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindu Sharma 
Designation  Scientist - 4 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy 61-65 Institutional Area Opp D Block Janakpuri New Delhi

South West
DELHI
110058
India 
Phone    
Fax    
Email  drbinduhomoeo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bindu Sharma 
Designation  Scientist - 4 
Affiliation  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy 61-65 Institutional Area Opp D Block Janakpuri New Delhi

South West
DELHI
110058
India 
Phone    
Fax    
Email  drbinduhomoeo@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy  
Address  61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi-110058 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr JS Arya  Clinical Research Unit (H)  Gokhel Road ( Near Bardakanta High School), Arbindo Pally, Siliguri - 734006
Darjiling
WEST BENGAL 
0353-2596065

cruslg@gmail.com 
Dr Kolli Raju  Clinical Research Unit (H)  B-32 IIIrd Cross Street A.G.S. Colony (Sea side) Kottivakkam Chennai
Kancheepuram
TAMIL NADU 
04424511821

cruchennai@gmail.com 
Dr RVR Prasad  Clinical Research Unit (H)  Old Maternity Hospital Campus Tirupati 517507
Chittoor
ANDHRA PRADESH 
04232595184

crutpt@gmail.com 
Dr S Bhuvaneswari  Clinical Research Unit (H)  No. 13,1st Cross, Mangalakshmi Nagar, (Behind New Bus Stand), Puducherry – 605013
Pondicherry
PONDICHERRY 
0413-2206879

crupuducherry@gmail.com 
Dr Hafeezullah Baig  Drug Standardisation Unit  O.U. B-32, Road No. 4, Vikrampuri, Habsiguda, Hyderabad, Andra Pradesh- 500 007
Hyderabad
ANDHRA PRADESH 
04027178188

drhafeezullahbaig@gmail.com 
Dr Ch Raveendar  Regional Research Institute (H)  Dr. GGH Medical College Campus Eluru Road Gudivada Krishna District 521 301
Krishna
ANDHRA PRADESH 
08674243491

rrihgudivada@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
EthicalCommitteeofCCRH New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Symptoms and Signs of Diabetic Polyneuropathy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Constitutional medicines- Arsenic album, Calcarea carbonica, Carbo vegetabilis, Conium maculatum, Kali carbonicum, Lycopodium clavatum, Phosphorus, Pulsatilla nigricans, Plumbum metallicum, Mercurius solubilis, Sulphur, Phosphoric acid, Natrum muriaticum, Nitric acid and Zincum metallicum  The treatment for each patient shall always begin with 6C potency and to be followed serially by next higher potency as per need of the case. A. 6C to be given thrice/day for 15 days. B. 30C twice/day for 15 days C. 200C once/day for 15 days D. 1M, one dose on day one and observe for 15 days. The medicine will be administered orally. 
Comparator Agent  Placebo  The patients will be prescribed identical placebo as the study is double blind placebo controlled trial. The route of administration will be oral. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Both sexes of age between 30-70 years.
Diagnosed cases of Type 2 Diabetes stable with allopathic treatment for last 3 months.
DNE ≥ 3
Abnormal Nerve conduction test.
HbA1C ≤ 8%.
Controlled Hypertension
Written Informed consent from the patient. 
 
ExclusionCriteria 
Details  i. Diabetic Mononeuropathy
ii. Diabetic Polyradiculopathy
iii. Diabetic amyotrophy
iv. Diabetic Autonomic Neuropathy
v. Abnormalities of gait
vi. Development of typical Charcot’s joints, particularly in the feet
vii. Loss of arch with multiple fractures of tarsal bones
viii. Wrist drop
ix. Foot drop
x. Paralysis of III, IV or VI Cranial Nerves
xi. Myocardial infarction less than 6 months
xii. Unstable angina
xiii. Neuropathy due to other causes e.g. Vitamin B12 deficiency.
xiv. Alcohol addiction or dependence
xv. Cases presenting with long term complication of diabetes such as severe retinopathy, severe renal involvement or with history of recurrent acute complications like hypoglycemia, ketoacidosis, polyneuropathy etc.
xvi. Subjects with ill managed diabetes i.e. glycosylated hemoglobin (HbA1c) more than 8%
xvii. Cases with other systemic diseases like cardiovascular, endocrinal diseases like thyroid dysfunction or Systemic infections or on other treatment therapies. (except for hypertensive and dyslipedemic patients on standard care) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the NTSS – 6  Change in the NTSS – 6 from baseline to 12 months post intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the changes in Serum glycosylated haemoglobin   3rd, 6th, 9th and 12th months between the groups 
To compare the Peripheral nerve conduction test and lipid profile   6 and 12 months between the groups 
To compare the changes in WHOQOL BREF   baseline 3rd, 6th, 9th and 12th month  
Change in Diabetic Neuropathy Examination Score   12 months  
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   03/08/2015 
Date of First Enrollment (Global)  No Date Specified 
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   Nil 
Brief Summary   The study is a double blind randomized placebo control clinical trial to see the efficacy of homoeopathic medicines on the symptoms and signs of Diabetic Polyneuropathy and also on the quality of life f patients suffering from this condition. 84 patients will be enrolled and will be followed for one year at six centers in India.  The primary outcome measure is to compare the Change in the NTSS – 6 from baseline to 12 months post intervention in both the groups. The Secondary outcome is to compare the changes in Serum glycosylated haemoglobin at 3rd, 6th, 9th and 12th months between the groups; to compare the Peripheral nerve conduction test and lipid profile at 6 and 12 months between the groups; to compare the changes in WHOQOL BREF at baseline 3rd, 6th, 9th and 12th month between the groups and change in Diabetic Neuropathy Examination Score at 12 months post intervention. 
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