| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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. |
|
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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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