| CTRI Number |
CTRI/2024/09/073711 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Ayurvedic formulation alongwith Metformin an allopathic drug in treatment of Madhumeha with reference to Type 2 Diabetes |
|
Scientific Title of Study
|
Randomized Controlled Open label Clinical trial to Study add on effect of Triphaladi Kashay alongwith Metformin in management of Madhumeha w.s.r to type 2 Diabetes Mellitus |
| 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 Unmesh Vikas Deshmukh |
| Designation |
MD Kayachikitsa Scholar(Ayurveda) |
| Affiliation |
Dr.VJD Gramin Ayurved Mahavidyalaya,Patur,Akola |
| Address |
Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola
Pin-444501
MAHARASHTRA
INDIA
Akola MAHARASHTRA 444501 India |
| Phone |
8446525624 |
| Fax |
|
| Email |
unmeshdeshmukh1198@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrJayshree Katole |
| Designation |
Professor and Head of the Department,Kayachikitsa |
| Affiliation |
Dr.VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD NO 3 Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola
Pin-444501
MAHARASHTRA
INDIA
Akola MAHARASHTRA 444501 India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrJayshree Katole |
| Designation |
Professor and Head of the Department,Kayachikitsa |
| Affiliation |
Dr.VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD NO 3,Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola
Pin-444501
MAHARASHTRA
INDIA
Akola MAHARASHTRA 444501 India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa,Dr VJD Gramin Ayurved Mahavidyalaya,Patur,Dist-Akola,Maharashtra,India Pin code -444501 |
|
|
Primary Sponsor
|
| Name |
Dr.VJD Gramin Ayurved Mahavidyalaya |
| Address |
Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola,Maharashtra,India Pin-444501 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Unmesh Vikas Deshmukh |
Dr.VJD Gramin Ayurved Mahavidyalaya |
OPD no.3 , Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Akola MAHARASHTRA |
8446525624
unmeshdeshmukh1198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,DR VJD Gramin Ayurved Mahavidyalaya,Patur, Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi Kashay, Reference: Bhaishajya Ratnavali Prameha Chikitsa 37/7, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Triphaladi Kashay 30 ml bd alongwith Tab Metformin 500 mg od | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin | Tab Metformin 500 mg od |
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing for clinical trial and written consent.
2. Age group from 30 to 70 yrs.
3. Patients with newly diagnosed as well as known case of type 2 diabetes mellitus already taking Tab. Metformin 500 mg only.
4. The patients having symptoms of prabhutmutrata, trushnadikya, kshudhadikya, daurbalya, alasya .
5.Blood Sugar Level (Fasting-120 to 159 mg/dl)
(Post prandial-160 to 250 mg/dl)
6.Hba1c 6.5 to 9
7. Patients without any complication of madhumeha (type 2 D.M.) or without any other systemic disorder. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing for clinical trial and written consent.
2. Sahaj and jatha janya madhumeha or patients with type 1 diabetes mellitus
3. Patients on insulin therapy or Steroid Therapy.
4. Patients having blood sugar more than 250mg/dl.
5.Subjects under any other oral hypoglycaemic therapy other than Tab.Metformin 500 mg
6. Patients having complication of madhumeha or any other systemic disorder like renal disorder, heart disease, Neurological,psychological disorder and Carcinoma.
7.Pregnant and Lactating Women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like1. Prabhutmutrata
2. Trushnadikya
3. Kshudhadhikya
4. Daurbalya
5.Alasya will be decreased and Control over Madhumeha with reference to Type 2 Diabetes Mellitus |
30 days,60 days,90 days after starting treatmemt |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Symptoms of Madhumeha and Control over BSL |
18 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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 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
|
Ayurveda is a natural health care system that originated in India since the beginning of civilization. It is described by Acharya Charak that to achieve purushartha chatushtaya, Arogya is necessary. Ayurveda strongly emphasize on preventive and promotive aspects of health rather than curative. The concepts of Dincharya, Ritucharya, Sadvritta and Achara Rasayana along with guidelines for healthy diet and lifestyle is well established in Ayurveda, but in current scenario, hardly any one follows it as a result ,there is tremendous rise in lifestyle disorders as pandemics, Diabetes being most menacing among them. Diabetes is fourth leading cause of global death by disease. Type 2 DM is responsible for approximately 90% of cases. Therefore today’s India is called nation of DM. Madhumeha "Richman’s disease", since Vedic period, is familiar to mankind. Madhumeha is a disease in which mutra (Urine) of the patient attains similar property like those of madhu (Honey). It is documented as one among the twenty obstinate urinary disorders i.e. Prameha. It is also explained that, when the other Prameha are left untreated, this lead to the condition called Madhumeha. So Madhumeha can also be considered as an advanced condition or stage of Prameha. Diabetes Mellitus is a chronic disorder of carbohydrate metabolism, marked by hyperglycemia and glycosuria and resulting from inadequate production or use of insulin. Traditionally, Madhumeha can be equated with diabetes mellitus, as many similarities in view of their causative factors, pathogenesis, signs and symptoms, classification, complications and treatment has been found. Diabetes mellitus is a clinical syndrome characterised by hyperglycemia caused by an absolute or relative deficiency of insulin & insulin resistance lack of insulin, whether absolute or relative, affects the metabolism of carbohydrates. Type II diabetes mellitus has become a global epidemic. Modern medicines, despite offering a variety of effective treatment options can have several adverse effects. Diabetes Mellitus is classified into 2 types. 1. Type I (IDDM/juvenile diabetes) 2. Type II (NIDDM/adult onset diabetes) With regard to diabetes mellitus, Sahaj prameha and kulaj prameha correlate with type I diabetes and apathyanimittaja prameha correlates with type II diabetes. According to Ayurveda Prameha is Included in one of the Mahagadas. In prameha maximum no. of strotas, all 7 Dhatus & ojas get involved & prameha shows group of many symptoms due to this condition of patient goes on deteriorating day by day. The Ayurvedic management of Diabetes aims not only to achieve a strict glycemic control but also to treat the main & root cause of disease. Many drugs & formulae have prescribed for internal & external use in Ayurved samhitas, one of which is “Triphaladi Kashay†.This thesis is an attempt to study the add on effect of “Triphaladi Kashay alongwith Metformin†in Madhumeha & improve the personal & social life of a patient, it is an effort of scholar to observe the add on effect of Triphaladi kashay alongwith Metformin in Madhumeha (NIDDM)
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