| CTRI Number |
CTRI/2019/02/017609 [Registered on: 12/02/2019] Trial Registered Prospectively |
| Last Modified On: |
14/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic Management on Type II Diabetes Mellitus. |
|
Scientific Title of Study
|
Randomized Controlled Clinical study on the efficacy of Vidangadi Lauha on Sthula Madhumeha with special reference to Type II Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Punam Khobarkar |
| Designation |
MD Kayachikitsa (PG Scholar) |
| Affiliation |
Government ayurved college nagpur |
| Address |
Department of Kayachikitsa, Government Ayurved College, Sakkardara Chawk, Nagpur.
Department of Kayachikitsa, Government Ayurved College, Sakkardara Chawk, Nagpur.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
8087871483 |
| Fax |
07122749198 |
| Email |
poonamkhobarkar10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gulhane D Jayant |
| Designation |
Associate Professor |
| Affiliation |
Government ayurved college nagpur |
| Address |
Department of Kayachikitsa, Government Ayurved College, Sakkardara Chawk, Nagpur.
Department of Kayachikitsa, Government Ayurved College, Sakkardara Chawk, Nagpur.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9822922399 |
| Fax |
07122749198 |
| Email |
jayant.gulhane.62.6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulhane D Jayant |
| Designation |
Associate Professor |
| Affiliation |
Government ayurved college nagpur |
| Address |
Department of Kayachikitsa, Government Ayurved College, Sakkardara Chawk, Nagpur.
Department of Kayachikitsa, Government Ayurved College, Sakkardara Chawk, Nagpur.
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9822922399 |
| Fax |
07122749198 |
| Email |
jayantgulhane@gmail.com |
|
|
Source of Monetary or Material Support
|
| self [Punam Khobarkar Department of Kayachikitsa Government Ayurved College Nagpur] |
|
|
Primary Sponsor
|
| Name |
Khobarkar Punam Self |
| Address |
Government Ayurved College Nagpur |
| Type of Sponsor |
Other [] |
|
|
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 |
| Punam Namdeo Khobarkar |
Government ayurved hospital nagpur |
Department of Kayachikitsa, Government Ayurvedic College Nagpur,Ayurvedic Layout, Raje raghuji nagar, Sakkardara chawk,Nagpur
Nagpur
MAHARASHTRA |
8087871483
07122749198
poonamkhobarkar10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurved College Nagpur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab. metformin 500mg |
Newly detected Sthula Madhumeha patients having fasting blood sugar level more than126mg/dl up to 200 mg/dl and post prandial blood sugar level more than 200mg/dl up to 300mg/dl and HBA1C up to 9%, as they visit opd and ipd of kayachikitsa department will be studied randomly irresspective of sex, religion, educational and economic status.complete clinical examination will be done to diagnose and assess the condition as per case record form.Tab metformin 500mg BD brfore meal given to the patients up to 3 months with follow up on every 30 days. Followed up and assessment done as per fix schedule.Particular complaints of the patients will be recorded , analysed and will be treated accordingly. Treatment will complete on 90 day and all parameters will be assessed and recorded which will be denoted as after treatment values. Investigations of all the patients will also be recorded before and after the treatment and they will be treated as before and after treatment scores respectively. In this series of patients of type II Diabetes Mellitus follow up will be taken after 1 month . Follow up assessment will also be done. |
| Intervention |
Vidangadi Lauha
(Vidang (Embelia ribes), Triphala (Emblica officinalis, Terminalia chebula, Terminalia bellerica), Musta (Cyperus rotandus), Kanaya (Piper longum), Nagar (Piper nigrum), Jirak (Cuminum cyminum), Krushna Jirak (Carum bulbocostanum), Lauha Bhasma ) |
- Vidangadi Lauha 5gm twice given to the patients up to 3 months with follow up on every 30 days with Koshnajal Anupan 100 ml. Procedures and assessments will be same as the comparator group
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly detected patients having fasting blood sugar level more than 126mg/dl and post prandial blood sugar level more than 200mg/dl (A.D.A 2015)
2. Newly detected patients fulfilling criteria of diagnosis and having signs and symptoms of Sthula Madhumeha (Diabetes Mellitus)
3. Patients having age between 30 to 70 years
4. HbA1c up to 9%
5. Patients having BMI more than 23 will be selected up to 30 (chamukuttan.s.2006)
6. Those are willing to participate in trial and ready to give written consent.
7. Patients with controlled Hypertension
|
|
| ExclusionCriteria |
| Details |
1. Patients having age below 30 and above 70.
2. Patients with fasting blood sugar level >200mg/dl and post meal blood sugar level>300mg/dl.
3. HbA1c more than 9%.
4. Patients having BMI less than 23 and above 30.
5. Patients who already taken anti Diabetic drugs
6. Patients having insulin dependent diabetes mellitus and juvenile diabetes
7. Patients having complications such as vasculopathy, nephropathy, retinopathy and neuropathy.
8. Those are not willing to participate in trial and not ready to give written consent.
9. Patients having other systemic complications like hepatic, renal and cardiac problems.
10. If any complication arises during treatment or if any patient discontinues the treatment these cases will be liable for rejection.
11. Patients having poorly controlled blood pressure.
12 .Pregnant and lactating females not included in this study.
13. Emergency cases in Type 2 Diabetes Mellitus.
14. Patients who are currently participating in any other clinical trials (since last 6 months)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect of Vidangadi Lauha on clinical features of Sthula Madhumeha ,blood sugar level,B.M.I. and hip waist ratio(Type II Diabetes Mellitus) and specifically on its parameters
2. To evaluate the effect of Tab metformin on clinical features of Sthula Madhumeha (Type II Diabetes Mellitus) and specifically on its Parameters.
3. To compare the effect of drug in Trial Group Vidangadi Lauha with that of drug in Control Group Tablet Metformin 500mg. |
1) On zero day assessments i. e. B.T. value
2) For Trial group Vidangadi Lauha 5 gm BD before meal for 3 month
3) For Control Group Tab. Metformin 500 mg BD before meal for 3 months
4) Follow up assessment will be done on 31rst ,61rst, day and Data will be analyzed statisticaly.
5) Final assessment will be done on 91rst day and statistical analysis will be done. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the literature of Madhumeha as per Ayurvedic perspective.
2. To study Madhumeha which is correlated with type 2 Diabetes mellitus with modern point of view.
|
One and half year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2019 |
| Date of Study Completion (India) |
31/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes Mellitus is a major public health challenge of the twenty-first century. Increasing Levels of Urbanization, Industrialization and economic advancement adversely affect the biological and environmental risk factors for Diabetes and other non-communicable diseases. Unhealthy diet, physical inactivity and stress factors cause overweight and insulin resistance1. This study entitled “Randomised Controlled Clinical Study on the Efficacy of Vidangadi Lauha on Sthula Madhumeha with special reference to Type II Diabetes Mellitus." All the parameters of assessment will be based on the signs and symptoms of Prameha mentioned in classics and the diagnostic criteria. Patients fulfilling the criteria will be selected and divided in two groups called trial and control group followed by a filling of consent form in language best understood by them. Control group patients will be administered by tab Metformin in a dose of 500 mg twice a day while in trial group patients will be going to manage with Vidangadi Lauha as above mentioned dose and timing. All the parameters will be assessed before and after treatment based on the specially prepared proforma, Appropriate test will be applied to the data outcome and discussion and conclusion will be made accordingly.Appropriate test will be applied to the data outcome and discussion and conclusion will be made accordingly. |