| CTRI Number |
CTRI/2018/07/014967 [Registered on: 19/07/2018] Trial Registered Prospectively |
| Last Modified On: |
18/07/2018 |
| 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
|
Role of Ayurveda Medication in complication of Diabetiese |
|
Scientific Title of Study
|
Evaluation Of Efficacy Of Vangeshwara Rasa In Diabetic Polyneuropathy- A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veer Vidya Ramaning |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya |
| Address |
OPD No 21 and IPD of Kayachikitsa - Rasayana & Vajikarana of KLE Ayurveda Hospital and Research Centre.
Belgaum
KARNATAKA
590003
India |
| Phone |
9765326862 |
| Fax |
|
| Email |
drvidyaveer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veer Vidya Ramaning |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya |
| Address |
OPD No 21 and IPD of Kayachikitsa - Rasayana & Vajikarana of KLE Ayurveda Hospital and Research Centre
Belgaum
KARNATAKA
590003
India |
| Phone |
9765326862 |
| Fax |
|
| Email |
drvidyaveer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suketha Kumari |
| Designation |
Assistant Professor Kayachikitsa Department |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya |
| Address |
OPD No 21 and IPD of Kayachikitsa - Rasayana & Vajikarana of KLE Ayurveda Hospital and Research Centre
Belgaum
KARNATAKA
590003
India |
| Phone |
9483637757 |
| Fax |
|
| Email |
sukethashetty411@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Veer Vidya Ramaning |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Veer Vidya Ramaning |
KLE Ayurveda Hospital and Research Centre |
OPD No 21 and IPD of Kayachikitsa - Rasayana & Vajikarana of KLE Ayurveda Hospital and Research Centre Shahapur Belagavi 590003
Belgaum
KARNATAKA |
9765326862
drvidyaveer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KAHERs Shri B M K Ayurveda Mahavidyalaya & KLE Ayurveda Hospital Shahapur Belagavi Karnataka 590003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
1. Metabolically stable diagnosed TYPE 2 Diabetes Mellitus (i.e FBS 126 & 140mg/dL AND PPBS 140mg/dL) patients with symptomatic Diabetic Polyneuropathy.
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A |
Koshtashodhana with Nimbamrutadi Eranda taila with milk- 1st day
Guduchyadi Kwatha 40 ml BD after food
Anupana – water
This drug will be administered for 43 days |
| Intervention |
GROUP B |
Koshtashodhana with Nimbamrutadi Eranda taila with milk- 1st day
Vangeshwara Rasa 125 mg tablet 1 BD
Anupana – water
This drug will be administered for 43 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Metabolically stable diagnosed TYPE 2 Diabetes Mellitus (i.e FBS >126 & <140mg/dL AND PPBS >140mg/dL) patients with symptomatic Diabetic Polyneuropathy.
2.Patients on Anti- diabetic medications will be included.
3.Patient of irrespective of sex, religion and socioeconomic status.
4.Patients with TCSS score between 6- 11.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Patients with other complications of DM such as Nephropathy, Retinopathy and Vasculopathy.
3.Patients with other metabolic and endocrinal disorders.
4.Patients with other causes of Neuropathy.
5.Patients with wound or ulcer.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vangeshwara Rasa is efficacious in managing the Diabetic Polyneuropathy.
Reduction in clinical Signs and symptoms of Diabetic Polyneuropathy.
|
0th, 15th, 30th, 46th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/10/2018 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes Mellitus is most prevalent
non communicable disease with common and serious complication like Diabetic
Polyneuropathy (DPN). Diabetic Polyneuropathy is
one of the most troublesome vascular complications of Diabetic Mellitus present
in 30 – 50 % of all Diabetics. Diabetes can be correlated with Madhumeha
in Ayurveda, but no equivalent explanation available for DPN.
Diabetic is the leading
cause of neuropathy ,and it is most common cause for complication and greatest
source of mortality and morbidity, one in 6 Diabetics has neuropathy is that up
to 50 % Diabetics . Diabetic Polyneuropathy is major cause
for lower limb amputation. The trial drug Vangeshwara Rasa is having sheeta
veerya drug with kashaya and tikta rasa. Previous study shown that Vangeshwara
rasa is highly efficatious than Vanga bhasma(calyx) for controlling the blood
glucose level in Diabetic patients. Diabetic Polyneuropathy is
severe but frequently reported and
inadequately treated , so there is a need of further research .
With this background here
is an attempt made to find out effective Ayurvedic formulation to treat
Diabetic Polyneuropathy. The formulations which are explained in classics for
Prameha in classics have been selected for the present study they are
Guduchyadi Kwatha and Vangeshwara Rasa.Hence the present study is aimed to know
the efficacy and safety of these
formulations in the management of Diabetic Polyneuropathy. |