FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075206 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effect of Homoeopathic medicine Cephalandra indica in treating Diabetic Kidney Disease 
Scientific Title of Study   A Clinical study on the efficiency of Homoeopathic medicine Cephalandra indica 6C in Managing Albuminuria and controlling Blood glucose levels in Diabetic nephropathy patients  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANJU T R 
Designation  PG SCHOLAR 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  ROOM No 3d1, Medical Unit IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  8921117233  
Fax    
Email  anjutr45@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. H. Venkatesan 
Designation  Professor and Head 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  ROOM No 3d1, Medical Unit IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  9865134561  
Fax    
Email  venkathompath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ANJU T R 
Designation  PG SCHOLAR 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  ROOM No 3d1, Medical Unit IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  8921117233  
Fax    
Email  anjutr45@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47,Sankari Main Road, Seeragapadi Po, Salem, Tamilnadu - 636308 
 
Primary Sponsor  
Name  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  NH 47,Sankari Main Road, Seeragapadi Po, Salem, Tamilnadu - 636308 
Type of Sponsor  Private medical college 
 
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 Anju T R  Vinayaka Missions Homoeopathic Medical College and Hospital  ROOM No 3d1, Medical Unit IV, PG Department of Practice of Medicine, Ground Floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO
Salem
TAMIL NADU 
8921117233

anjutr45@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vinayaka Missions Kirubanandha Variyar Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cephalandra indica 6C  4 medicated pills (30 size) per oral route daily two doses for 120 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  HbA1C: 6.5% - 9.5%
ACR: 30-299 mg/g
eGFR: 60-90ml/min/1.73m2
 
 
ExclusionCriteria 
Details  Diabetic patients with other complications
Patients with end stage renal disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Reduction in ACR
2.Reduction in blood glucose level 
120 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Increase in eGFR
2.Reduction in Urine albumin
3.Reduction in Fasting Blood Glucose levels 
120 Days 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) 26/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Diabetic nephropathy is the leading cause of renal replacement therapy and affects ∼40% of Type 1 and Type 2 diabetic patients. It increases the risk of death and is defined by increased Urinary Albumin Excretion (UAE) in the absence of other renal diseases. Diabetic kidney disease and End Stage Renal Disease (ESRD) have the most debilitating consequences among all diabetes complications. While considerable advances have been achieved in slowing the progression of diabetic nephropathy, the ultimate goal of arresting or reversing disease development is not achieved. Diabetic nephropathy is categorized into stages: microalbuminuria (UAE >20 μg/min and ≤199
μg/min) and macroalbuminuria (UAE ≥200 μg/min). Hyperglycemia is the main risk factors for the development of diabetic nephropathy. Screening for microalbuminuria should be performed yearly, starting 5 years after diagnosis in Type 1 diabetes or earlier in the presence of puberty or poor metabolic control. In patients with Type 2 diabetes, screening should be performed at diagnosis and yearly thereafter. Patients with micro- and macroalbuminuria should undergo an evaluation regarding the presence of comorbid associations, especially retinopathy and macrovascular disease. Achieving the best metabolic control (HbA1c <7%), treating systemic hypertension (<130/80 mm of Hg or <125/75 mm of Hg if proteinuria >1.0 gm/24 hrs and increased serum creatinine), and treating dyslipidemia (LDL cholesterol <100 mg/dl) are effective strategies for preventing the development of microalbuminuria, in delaying the progression to more advanced stages of nephropathy and in reducing mortality in patients with Type 2 diabetes. 
Cephalandra indica
Cephalandra indica, Coccinia cordifolia (L.) Cogn), commonly known as Ivy Gourd, Little Gourd and Kovai belongs to family Cucurbitaceae. The plant had been used in Ayurvedic and Unani practice in the Indian subcontinent, as antidiabetic. C. indica is traditionally used as anti-inflammatory, antipyretic, analgesic, antispasmodic, antimicrobial, cathartic, antibacterial and expectorant. Terpenoids, steroids, carotenoids and flavonoid have been isolated from C. indica aerial parts. Cephalandra indica belongs to family Cucurbitaceae, also known as Kundru in Hindi and Ivy Gourd in English, is a perennial climbing herb with tuberous roots that grows in the wild in abundance in major parts of India. The plant has been used since ancient times for treating diabetes mellitus according to the science of Ayurveda.C.indica has been reported to have an insulin stimulating effect on β cells. The usefulness of C. indica for diabetes mellitus in mother tincture in Homeopathy has also been documented through case reports . Chemical constituents: The whole plant contains various phytochemical constituents such as triterpenoids, steroids, carotenoids, aliphatic hydrocarbons and certain vitamins. ANTIDIABETIC ACTIVITY These mechanisms of action include stimulation of insulin secretion, regeneration of β-cells, restoration of antioxidant enzymes, enhancement of glucose uptake, regulation of metabolic enzymes, amelioration of lipid profiles, and inhibition of digestive enzymes. Here we summarize how C. grandis exerts antidiabetic activity via the aforementioned mechanisms of action.
Clinical studies: C. indica is used to treat “sugar urine” (madhumeha) in Ayurveda, a traditional Indian healing system. The mechanism of action is not well understood but appears to have insulin-mimetic properties. While assessing the quality of the herb for glycemic control by the American Diabetes Association Criteria for Clinical Guidelines, which rated C. indica with an A-rating and having supportive evidence with at least one adequate randomized clinical trial. Pharmacological reports: C. indica has been reported to exhibit anti-inflammatory, antipyretic, antimicrobial, antidiabetic, antiulcer and antioxidant activities. A survey of literature revealed
that though few scientific reports have validated traditional claims of C. indica aerial parts but employed crude uncharacterized extracts.

Since there is difficulty in management and insufficient treatment methods so far for Diabeteis and Nephropathy, this research study on Cephalandra indica is proposed. 

 
Close