| CTRI Number |
CTRI/2019/01/016983 [Registered on: 08/01/2019] Trial Registered Prospectively |
| Last Modified On: |
04/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study on the effect of an Ayurvedic Treatment on diabetic mellitus patients having neuropathy in the limbs. |
|
Scientific Title of Study
|
An Open Label Comparative Clinical Study To Assess The Effect Of Dasamoolaksheeradhara As An Add On Therapy With Standard Care In Conventional Medicine In Diabetic Neuropathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| E.17AYU6AYU1004 dated 01 July 2017 Version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnjaly NV |
| Designation |
Principal Investigator |
| Affiliation |
Sreedhareeyam Ayurvedic Eye Hospital and Research Center |
| Address |
Soubhadram Ward
Sreedhareyam Ayurvedic Eye Hospital and Research Center
Nelliakkatuumana,Kizhakombu,Koothattukulam
Ernakulam
KERALA
686662
India |
| Phone |
|
| Fax |
|
| Email |
dranjaly@sreedhareeyam.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashankar Mund |
| Designation |
Guide |
| Affiliation |
Mandsar University |
| Address |
Professor & HOD
Department of Basic Principles
Mandsaur Institute of Ayurved Education & Research
Mandsaur
Mandsaur
MADHYA PRADESH
458001
India |
| Phone |
|
| Fax |
|
| Email |
principal.ayurved@meu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrJayashamkar Mund |
| Designation |
Guide |
| Affiliation |
Mandsar University |
| Address |
Professor & HOD
Department of Basic Principles
Mandsaur Institute of Ayurved Education & Research
Mandsaur
Mandsaur
MADHYA PRADESH
458001
India |
| Phone |
|
| Fax |
|
| Email |
principal.ayurved@meu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.Anjaly NV
SMO
Soubhadram Ward
Sreedhareeyam Ayurvedic Eye Hospital and Research Center
Nelliakkattu Mana
Kizhakombu
Koothattukulam
Ernakulam Dist
Kerala 686662 |
|
|
Primary Sponsor
|
| Name |
Dr Anjaly NV |
| Address |
SMO , Soubhadram Ward Sreedhareeyam Ayurvedic Eye Hospital and Research Center Nelliakkattu Mana Kizhakombu Koothattukulam Ernakulam Dist Kerala 686662 |
| Type of Sponsor |
Other [Investigator Initiated Study] |
|
|
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 |
| DrAnjaly NV |
Sreedhareeyam Ayurvedic Eye Hospital and Research Center |
Roon N0.3109
Soubhadram Ward
Nelliakkattu Mana
Kizhakombu,Koothattukulam
Ernakulam Dist
Kerala
Ernakulam
KERALA |
9745005913
dranjaly@sreedhareeyam.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Mandsaur Institute of Ayurved Education and Research,Bhunyakhedi, Madhya Pradesh 458001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional modern medicine. |
oral medication as specified by the modern practioner for 45 days |
| Intervention |
Dasamoola Ksheera Dhara Treatment |
External application once daily for 30 minutes 14 days along with conventional modern medicine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of diabetic neuropathy fulfilling the diagnostic criteria.
Patients having hemoglobin A1c(HbA1c) >6.5% at screening.
Patient having FBS ≤200 mg/dL at screening.
Patients currently treated with Standerd care in Modern medicine.
Patient willing to give a signed informed consent form prior to start of the study.
|
|
| ExclusionCriteria |
| Details |
Patient has hypersensitivity to any of the study medications
Patient is a nursing mother, Pregnant.
Patient has used injected anesthetics or steroids within 30 days of baseline.
Known cases of Skinleisons, malignancy,, any non-diabetic neurologic disorders, seriouds health issues
Patient has certain conditions that could confound evaluation of DPN, in particular, amputations other than toes, (e.g. phantom limb pain), and skin conditions affecting sensation in painful limbs.
Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
Patient is in an immunocompromised state.
Patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant.
Patient has a history of pernicious anemia, untreated hypothyroidism, chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.
Patient has any other serious medical condition.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Biothesio Meter |
Day 1,Day 15,Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HbA1C |
Day 1,Day 45 |
| Blood Glucose Levels |
Day 1,Day 15,Day 45 |
| Neuropathy Total Symptom Score, |
Day 1,Day 15,Day 45 |
| Michigan Neuropathy Screening Instrument |
Day 1,Day 15,Day 45 |
| Quality of Life using Nottingham health profile |
Day 1,Day 15,Day 45 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/01/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetic foot accounts for one of the largest in
patients admissions in India. The neuropathies are the most common long-term complications of diabetes,
affecting up to 50% of patients. There are many patients even with
good glycemic control and oral medications complaining of neuropathic symptoms
such as burning sensation,numbness etc.Dasamoola Ksheera
dhara can be used as a cost effective and instantaneous solution to the menace
of Diabetic Peripheral Neuropathy |