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CTRI Number  CTRI/2024/08/072218 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Open Randomized Comparative Clinical Study Of 2 Drugs Madhumehaher Yog And Chandraprabha Vati In The Management Of Madhumeha With Special Reference To Type 2 Diabetes Melitus 
Scientific Title of Study   An Open Randomized Comparative Clinical Study Of Madhumehaher Yog And Chandraprabha Vati In The Management Of Madhumeha With Special Reference To Type 2 Diabetes Melitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aishwarya Santosh Kamble 
Designation  PG Scholar 
Affiliation  APMS ayurved mahavidyalaya, sion 
Address  Department of kayachikitsa,APMs Ayurved Mahavidyalaya, near sion station, sion,east, mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9860916842  
Fax    
Email  kambleaish1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Hemant Paradkar 
Designation  Associate Professor 
Affiliation  APMS ayurved mahavidyalaya, sion 
Address  Department of Kayachikitsa, APMs Ayurved Mahavidyalaya, Near Sion Station, Sion, East, Mumbai 400022.

Mumbai
MAHARASHTRA
400022
India 
Phone  9987519315  
Fax    
Email  hemant.paradkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aishwarya Santosh Kamble 
Designation  PG Scholar 
Affiliation  APMS ayurved mahavidyalaya, sion 
Address  Department of kayachikitsa, APMs Ayurved Mahavidyalaya, near sion railway station, sion, east, mumbai 400022

Mumbai
MAHARASHTRA
400022
India 
Phone  9860916842  
Fax    
Email  kambleaish1996@gmail.com  
 
Source of Monetary or Material Support  
APMs Ayurved Mahavidyalaya and Seth R.V Ayurvedic hospital, Sion,Mumbai 400022 
 
Primary Sponsor  
Name  APMs Ayurved Mahavidyalaya 
Address  Near Sion Station, Sion East, Mumbai 400022 
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 Aishwarya Santosh Kamble  APMs Ayurved Mahavidyalaya And Seth R.V. Ayurvedic Hospital  Kayachikitsa department, fourth floor, rom no-2, Near Sion Station, Sion East, Mumbai 400022
Mumbai
MAHARASHTRA 
9860916842

kambleaish1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
APMs Ayurved Mahavidyalaya Sion  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Madhumehaheryog, Reference: Sidhaprayoglatika, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Chandraprabhavati, Reference: Bhaishajyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  BSL- fasting 110mg/dl to 150mg/dl and/or post prandial 140mg/dl to 180mg/dl, only type 2 diabetes people, blood sugar in the inclusion range even with oral hypoglycemic drugs, newly diagnosed patients with hyperglycemia, patients having symptoms of diabetes - polyuria, polydipsia, polyphagia, extreme fatigue,blurred vision, numbness or tingling in hands or feet. 
 
ExclusionCriteria 
Details  Patients on insulin therapy
Patients with nephropathy, retinopathy,H/O diabetes ketoacidosis
Pregnant women and lactating mothers
Patients with type 1 diabetes
Patients on steroids
Immunocompromised patients
Patients with diabetic wounds and non-healing ulcers. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Blood Sugar level (BSL)
Fasting plasma glucose
Post-prandial plasma glucose
Urine glucose level (fasting and post prandial)
Weight
BMI
Abdominal Circumference
Mid-arm circumference
 
Baseline, on 30th day and on 60th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Prabhut Mutrata
Avil Mutrata
Pipasa Adhikya
Ati Kshudha
Ati Nidra
Alasya
Daourbalya
Klama
Kara-pada daha
Kara-pada suptata
Prabhut Sweda 
Base line, 15th day, 30th day, 45th day and 60th day.
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   17/08/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Diabetes is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. Symptoms of marked hyperglycemia include polyuria, polydipsia, polyphagia, and weight loss or gain. Based on similarities in signs and symptoms type 2 diabetes mellitus can be compared to its Madhumeha in Ayurveda. All the types of Prameha if not treated in time develop in Madhumeha. Ayurveda also believes that Madhumeha is Medodhatu dushtijanya vyadhi, underlying its connection with obesity and a sedantary lifestyle.
The key causes of Madhumeha are lack of exercise, poor dietary practices, heavy consumption of food containing Snigdha (unctuousness) and Guru (heavy) Guna and food that causes Kapha dosha vitiation. Ayurveda elaborated about Madhumeha in detail classifying it into 2 types - Santarpanottha & Apatarpanottha. The treatment modalities in Ayurveda include - Apataran, Medoghna Chikitsa, Dhatavagnideepan, Prasadan, Shaman Aushadhi, and Shodhan chikitsa.The study involves an open randomized comparative clinical study of Madhumehaher yog and Chandraprabhavati in the management of Madhumeha with special reference to Type-2 Diabetes Mellitus. Madhumehaher yog includes each 1 part: Haritaki, Bibhitaki, Amalaki, Nagjivha, Jambu, Nimba, Madhunashini, Chiraita, Kutki, Methika, Tejpatra. Chandraprabhavati includes: Chandraprabha, Vacha, Musta, Chiraita, Devdaru, Harida, Daruharidra, Ativisha, Pimpalimule, Chitrak, Trivrut, Dantimool, Ela, Tamalpatra, Twak, Vanshalochan, Dhanyak, Haritaki, Bibhitaki, Amalaki, Chavya, Vidang, Gajapippali, Suvarna Makshik, Sunthi, Marich, Pimpli, Javakhar, Sajjkshar, Saindhav, Padalavan, Bidalavan, Lohabhasma, Khadisakhar, Shilajit, Guggul.The study is carried out on 60 patients for 30 days. To evaluate the efficacy of trial drug in numerical data, Paired T-test and ordinal data Mann Whitney test. After drug and disease review collection and preparation of drug will be done, followed by drug authentication and standardization. Clinical features are taken as parameters to study drug effects and collected data will be presented. Statistical analysis and interpretation will be done.


 
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