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CTRI Number  CTRI/2025/07/091638 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A Study To See If A Homoeopathic Medicine Called Cephalandra Indica Can Help In Treatment Of Type 2 Diabetes Mellitus 
Scientific Title of Study   An Experimental Randomized Clinical Study Of Efficacy Of Homoeopathic Plant Remedy Cephalandra Indica Q In Management Of Diabetes Mellitus Type 2 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Reenal Manish Bhagat 
Designation  MD Scholar Part 2 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat India 
Address  Department Of Homoeopathic Pharmacy Division Of MD Second Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  7227010007  
Fax    
Email  rb23091998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Santosh Mahale 
Designation  Professor Of Homoeopathic Pharmacy Department 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat India 
Address  Department Of Homoeopathic Pharmacy Division Of MD Second Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9825290925  
Fax    
Email  rajeshmahale4u@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Santosh Mahale 
Designation  Professor Of Homoeopathic Pharmacy Department 
Affiliation  C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat India 
Address  Department Of Homoeopathic Pharmacy Division Of MD Second Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9825290925  
Fax    
Email  rajeshmahale4u@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat India 395001 
 
Primary Sponsor  
Name  C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat India 
Address  Department Of Homoeopathic Pharmacy Division Of MD Second Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat 
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 Reenal Manish Bhagat   C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat India 395001  Department Of Homoeopathic Pharmacy Division Of MD Second Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat
Surat
GUJARAT 
7227010007

rb23091998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of C D Pachchigar College of Homoeopathic Medicine And Hopsital surat gujarat india 395001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CEPHALANDRA INDICA HOMOEOPATHIC MOTHER TINCTURE   Homoeopathic Mother Tincture Cephalandra Indica will be given based on indications. The dose is 1 drop for each kg of body weight, divided into 3 equal parts. Each part will be mixed with 30 ml of water and taken three times a day orally. Intervention will be done in 7 to 15 days and as per requirement. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients of both sexes
Patients of age 35 to 75
Patients suffering from non insulin dependent type 2 Diabetes Mellitus willing to partcipate and taking treatment regularly and cooperating for regular follow up
FBS more than 126 mg per dl and PPBS more than 200 mg per dl and HBA1C more than 6.5
 
 
ExclusionCriteria 
Details  Patients with complications of Diabetes Mellitus
Patients with insulin dependent Diabetes
Patients who are immunocompromised either by disease or by medication
Patients who require emergency medical intervention 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate effectiveness of Homoeopathic Mother Tincture Cephalandra Indica in management of Diabetes Mellitus Type 2 Patients  9 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To Assess Impact Of Mother Tincture Cephalandra Indica On Associated Symptoms Of Diabetes Such As Excessive Thirst And Excessive Hunger And Frequent Urination  9 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   07/08/2025 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
NEED FOR STUDY
Type 2 diabetes now presents as one of the great pandemics of the 21st Century. In some population more than half of adults either already have the disease or are at high risk with evidence of impaired glucose tolerance, impaired fasting glycaemic or metabolic syndrome. It affects all people particularly some of our rapidly developing groups. India already faces a grave problem with the largest number of subjects with diabetes is expected to escalate further, with the number increasing to 70 million in the year 2025 and over 80 million by the year 2030. Treatment of diabetes mellitus with synthetic drugs often fails to provide desired results and comes with a lot of side effects. Homoeopathy is one of the most widespread systems of medicine which seeks to cure in accordance with natural laws of healing and uses medicine made of natural substance. Plants serve as a raw material or drug for approximately 80 percent of the medicines used in homoeopathy. There are many plants available that provide various alkaloids and phytochemicals that act as a potent inhibitor of glucose. Cephalandra is one amongst them with antihyperglycemic properties. A study conducted by Central Council for Research in Homoeopathy in the past on Albino rat model showed pancreatic beta cell- regeneration, inhibition in the uptake of glucose and reduction of blood sugar levels with the mother tincture of Cephalandra indica. This medicine lacks a thorough proving on human subjects. In homoeopathy, more detailed evidence based clinical study of Cephalandra indica is required on diabetes mellitus especially to bring down glucose levels with the help of mother tincture.
Hence, this study is an attempt to highlight the efficacy of Cephalandra indica Q in maintenance of blood sugar levels in human subjects suffering from diabetes mellitus type 2.

REVIEW OF LITERATURE

Diabetes Mellitus
Definition:
Diabetes mellitus is a group of metabolic diseases characterized by hyperglycaemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with long term damage, dysfunction, and failure of various organs, especially the eyes, kidneys, nerves, heart, and blood vessels. 
Prevalence:
The prevalence of diabetes is alarmingly high in India, so much so that it is referred to as the world’s diabetes capital. Presently, an estimated 40 million Indian citizens are diabetic, a figure that is predicted to surge to approximately 70 million by 2025. Consequently, it’s implied that by that period, one out of every five diabetics worldwide would be an Indian. 

Types of Diabetes:
1 Diabetes Mellitus
2 Diabetes Insipidus
3 Gestational diabetes
4 Impaired glucose tolerance Borderline diabetes
Type 1 diabetes typically arises from an autoimmune response that destroys the insulin-producing beta cells in the pancreas, resulting in a significant lack of insulin. On the other hand, type 2 diabetes is characterised by a reduced responsiveness to insulin’s action, combined with a failure to generate enough insulin to compensate for this insulin resistance.

Causes:
The causes of Diabetes Mellitus Type I are believed to include factors such as genetic susceptibility, the hygiene hypothesis, and stress, while the causes of Type II Diabetes Mellitus are often tied to lifestyle changes like inadequate diet and obesity. 

Symptoms:
The symptoms of diabetes mellitus can vary widely among individuals, with common symptoms being linked to high blood sugar levels, leading to excessive urination, increased thirst, and increased
hunger. Type 2 diabetes mellitus clinical features are Polyuria, thirst, weakness or fatigue, polyphagia with weight loss, recurrent blurred vision, vulvovaginitis or pruritus, peripheral neuropathy, nocturnal enuresis. In Type 2 Diabetes, symptom progression can lead to various Microvascular and Macrovascular Complications.

Diagnosis:
A fasting blood glucose level equal to or over 126 mg per dL after an 8 hour fast indicates diabetes.
An oral glucose tolerance test result showing a blood glucose level equal to or over 200 mg per dL two hours after consuming a drink containing 75 grams of glucose dissolved in water.
A random blood glucose level of 200 mg per dL or higher, taken at any time during the day.
A postprandial blood sugar measurement equal to or more than 200 mg per dl taken 2 hours after the meal.
HBA1C Test: The A1C test measures your average blood sugar level over the past 2 or 3 months. An A1C OF 6.5 percent or higher indicates diabetes.
Urine analysis test- Benedict test.

Management:
In new cases of diabetes, adequate glycaemic control can be obtained by diet and lifestyle advice alone in some. some people will need oral anti- diabetic medication, and some will require insulin. Homoeopathy is a system of Medicine that was first put into use by Samuel Hahnemann. For the better good of the mankind he introduced this system of medicine and it has served its purpose. Homoeopathy has long been in use for the treatment of diabetes. With its wide range of medicines to treat diabetes it can play an important part in the treatment. Plants serve as a raw material or drug for approximately 80 percent of the medicines used in homoeopathy. There are many plants available that provide various alkaloids and phytochemicals that act as a potent inhibitor of glucose. However, in this review we have tried to concentrate our gaze on one plant which is used in the homoeopathic treatment of diabetes Cephalandra indica. Others are: Syzygium jambolanum, Gymnema sylvestre.

Cephalandra indica
Cephalandra indica commonly known as Ivy gourd, little gourd, Kovai belongs to family Cucurbitaceae. It is used for hypoglycaemic and anti diabetic activities in homoeopathy and other system of traditional medicine. It contains an enzyme with amylolytic properties, a hormone and traces of an alkaloid and it produces reduction of sugar in the blood and urine of patients suffering from glycosuria. The present review attempts to encompass the available literature on Cephalandra indica with respect to its morphological characters, phytochemistry, summary of its various pharmacological activities and traditional and homoeopathic uses. 

Introduction:
The World Health Organization estimated near about 80 percent of world population both in developing and developed countries use herbal drugs for various ailments. This plant is one of the tremendous plants of Homoeopathy system. Cephalandra indica is widely used for hypoglycemic and anti-diabetic activities in ayurvedic system of medicine. The whole plant of Cephalandra indica having pharmacological activities like Anti diabetic, Antibacterial, Antitussive, Antimicrobial, Antioxidant, Anti inflammatory, Hyperlipidemic, Hepatoprotective, Chemoprotective. Synonym: Coccinia grandis, Coccinia cordifolia, Coccinia Indica, Physedra, Staphylosyce.

History and distribution:
In India Cephalandra indica grows in large quantities and widely distributed in Andhra Pradesh, Tamil Nadu, Kerala and Lakshadweep.
Scientific Classification:
Kingdom Plantae
Botanical name Cephalandra indica naud
Order: Cucurbitales Family Cucurbitaceae
Synonyms Coccinia cordifolia Telakucha

Description
1. It is a perennial creeping herb
2. Leaves Deep green leaves, alternate, palmately lobed, palmi veined, exstipulate
3. Flowers white, appear in July
4. Fruit A smooth cylindrical berry.
5. Root Long, tapering, tuberous
Part used The fresh green leaves 

Phytochemical Constituent:
Cephalandra indica contains
Alkaloids, flavonoids, fatty acids, as major chemical constituents. Aspartic acid, Glutamic acid, Asparaginase, Tyrosine, Histidine, Phenylalanine, Threonine, Valine.

Pharmacological Profile:
Cephalandra indica exhibits following pharmacological activities.
Antidiabetic activity
Anti-inflammatory and analgesic activity
Antibacterial activity
Hepatoprotective activity
Anti Hyper lipidemic activity
Antiulcerogenic activity 

Indications:
Diabetes mellitus with skin affections
Intolerable burning sensation in body
Profuse micturition, polyuria, sugar in urine
Dryness of mouth with great thirst
Boils, abscess, carbuncles
Over-sensitive to noise and external impression
 
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