| CTRI Number |
CTRI/2023/10/059281 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
17/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To find the difference between Mushkakadigana enema followed by Mushkakadigana tablet versus Tablet Metformin in the treatment of diabetes |
|
Scientific Title of Study
|
Evaluation of Comparative efficacy of Mushkakadigana Yoga Vasti followed by Mushkakadigana Vati Versus Standard treatment Tab Metformin in the management of Diabetes Mellitus Type 2 Prameha |
| 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 Vivek Goswami |
| Designation |
PG SCHOLAR |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH |
| Address |
room no 40 department of panchakarma mahatma gandhi ayueved College Hospital
and Research Centre
Mahatma Gandhi Ayurved College Hospital
and Research Centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
7000740949 |
| Fax |
|
| Email |
vuniversal5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Goswami |
| Designation |
PG SCHOLAR |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH |
| Address |
room no 40 department of panchakarma mahatma gandhi ayueved College Hospital
and Research Centre
Mahatma Gandhi Ayurved College Hospital
and Research Centre
MAHARASHTRA
442001
India |
| Phone |
7000740949 |
| Fax |
|
| Email |
vuniversal5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punam Sawarkar |
| Designation |
Associate Professor |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH |
| Address |
room no 40 department of panchakarma mahatma gandhi ayueved college hospital and research centre hirapur salod wardha
Mahatma Gandhi Ayurved College Hospital
and Research Centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860667023 |
| Fax |
|
| Email |
drsuple.punam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma gandhi ayurved college hospital and research centre hirapur salod wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma gandhi ayurved college hospital and research centre hirapur salod wardha |
| Address |
room no 40 department of panchakarma mahatma gandhi ayueved college hospital and research centre hirapur salod wardha |
| 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 Vivek Goswami |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room no 40 department of
panchakarma
Wardha
MAHARASHTRA |
7000740949
vuniversal5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| mahatma gandhi ayurved college hospital and research centre institutional ethics committee salod wardha |
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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Ashtang Hriday , Procedure details: (1) Medicine Name: Mushkakadigana yog vasti )
(1) Medicine Name: Mushkakadigana yog vasti, Reference: Ashtang Hriday , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 840(ml), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet metformin | Tablet Metformin 500mg OD |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Diabetic Patients willing to give written informed consent
2 Patient with either sex having age between 20 to 60 years
3 Patients recently diagnosed for uncomplicated NIDDM type two diabetes less then 6 month and having
Fasting blood sugar level greater than 100 to 125 mg per dl
Post meal blood sugar level greater than 140 to 300 mg per dl
4 Patients with and old cases of type two DM not taking any other anti-hypoglycemic drugs
5 Diabetic Patients suffering from Controlled Hypertension Blood Pressure not more then 140 mmHg or an average Diastolic Blood Pressure not more than 90mmHg
6 Patient fit for Basti Karma as per the Ayurvedic classics
|
|
| ExclusionCriteria |
| Details |
1 Patients suffering from IDDM Insulin dependent diabetes mellitus and patient with Type two Diabetes patient on insulin therapy
2 Patients suffering from Juvenile Diabetes or Gestational diabetes ICD 10 criteria 024
3 Impaired glucose tolerance ICD 10 criteria R73.0
4 DM with complications Retinopathy Nephropathy neuropathy previous history of coma
5 Patients suffering from any current acute illness uncontrolled hypertension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess the efficacy of Mushkakadigana Yoga Vasti followed by Mushkakadigana Vati Versus Standard treatment Tab Metformin in the Blood sugar levels Fasting and Post prandial and
Urine Sugar Level |
8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the efficacy of Mushkakadigana Yoga Vasti followed by Mushkakadigana Vati Versus Standard treatment Tab Metformin in the management of prameha type two Diabetes mellitus |
1 week 1 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)
|
02/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/11/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a parallel group, randomized, open clinical, standard controlled trial. it will include a 8 days treatment period and at 9th 24th and 45 day follow up period |