| 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
|
|
|
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
|
|
|
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.
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