CTRI Number |
CTRI/2023/08/056468 [Registered on: 14/08/2023] Trial Registered Prospectively |
Last Modified On: |
09/08/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A Clinical trial to study the effect of Vajra Guggulu in the management of Diabetic Neuropathy |
Scientific Title of Study
|
Open Labelled Active Controlled Randomised Evaluation of Vajra Guggulu in the Management of Diabetic Neuropathy |
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 Ankit Kumar |
Designation |
PG Scholar |
Affiliation |
Parul Institute of Ayurveda |
Address |
OPD No 116 Department of Kayachikitsa Parul Ayurveda Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
8527738148 |
Fax |
|
Email |
rockingdeshant@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shailesh V Deshpande |
Designation |
Professor |
Affiliation |
Parul Institute of Ayurveda |
Address |
OPD No 116 Department of Kayachikitsa Parul Ayurveda Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
9763104451 |
Fax |
|
Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vaishali S Deshpande |
Designation |
Professor |
Affiliation |
Parul Institute of Ayurveda & Research |
Address |
OPD No 08 Department of Kayachikitsa Khemdas Ayurved Hospital Parul University Ishwarpura Vadodara Gujarat
Vadodara GUJARAT 391760 India |
Phone |
9096082950 |
Fax |
|
Email |
dr.vaishalid@gmail.com |
|
Source of Monetary or Material Support
|
Parul Institute of Ayurved, Parul University |
|
Primary Sponsor
|
Name |
Principal Parul Institute of Ayurved |
Address |
Faculty of Ayurved, Parul University AP Limda TAL Waghodia DIST Vadodara Gujarat |
Type of Sponsor |
Private medical college |
|
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 Ankit Kumar |
Parul Ayurveda Hospital |
OPD No 116 Department of Kayachikitsa Parul Ayurveda Hospital Parul University AP Limda Tal Waghodia 391760 Vadodara Gujarat Vadodara GUJARAT |
08527738148
rockingdeshant@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Parul Institute of Ayurved- Institutional Ethics Committee |
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. Ayurveda Condition: PRAMEHA-UPADRAVAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vajra Guggulu, Reference: Rasratnakar/ Vaatrakta , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | 2 | Comparator Arm (Non Ayurveda) | | - | Pregabalin | Dose: 150 mg BD, Route: Oral, Dosage form: Tablet, Duration: 3 Months |
|
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Age- 40-70 years (both years inclusive).
2.Gender- Both male and female.
3.Known cases of Diabetes mellitus with symptoms of Diabetic Neuropathy.
4.Patients with good to moderate glycemic control.
5.Patients with MNSI Questionnaire score of ≥7 and MNSI Examination Score of ≥2.5.
6.Patients showing altered Vibratory perception of sensory stimulus on the basis of Bio-thesiometer. |
|
ExclusionCriteria |
Details |
Patients suffering from any of the following diseases:
1.Rheumatic disease.
2.K/C/O Vitamin deficiency.
3.Alcoholism and any other drug abuse.
4.K/C/O Paraneoplastic disorder and any other SOL causing nerve dysfunction.
5.K/C/O Cerebral vascular disease.
6.K/C/O Parkinsonism and any other nerve degenerative disorders.
7.K/C/O Leprosy, HIV-AIDS, STDs, and other immune-compromised conditions.
8.Patients with acute complications of Diabetes mellitus.
9.K/C/O uncontrolled Hypertension.
10.Patients with known allergy to any drug ingredients of study medicine in trial group and control group. |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Comparision of effect of Vajra Guggulu with Pregabalin in patients of Diabetic Neuropathy |
Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Compare the efficacy of Vajra Guggulu & Pregabalin in patient of Diabetic neuropathy on the basis of Biothesiometer & Michigan Neuropathy Screening Instrument. |
Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90 |
Compare the efficacy of Vajra Guggulu & Pregabalin in patient of Diabetic neuropathy on the basis of symptoms observed in patients. |
Baseline, Day15, Day30, Day 45, Day60, Day75, Day 90 |
Compare the safety of Vajra Guggulu & Pregabalin on the basis of adverse events & biochemical parameters – hemogram, renal & hepatic function test, urine routine & microscopic & glycosylated haemoglobin. |
Baseline, Day 90 |
|
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 |
Date of First Enrollment (India)
|
21/08/2023 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
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
|
Diabetic
Neuropathy (DN) is an early and common complication affecting approximately 50%
of the Diabetic patients. DN is caused by degeneration of myelinated and
non-myelinated nerve fibers. It most commonly presents as diminished perception
of sensation of vibration in distal part of limbs in glove and stocking
pattern, impairment of perception of sensory stimuli, loss of tendon reflexes, etc.
In patients showing symptoms predominant sensory abnormalities include paraesthesia
in feet, pain in limbs, burning sensation in palms and soles, cutaneous
hyperesthesia, numbness in feet. Muscle weakness and wasting develop in advanced
stages of DN. Line of treatment in contemporary system of medicine focuses
mainly on strict glycemic control with anti-convulsant (gabapentin, pregabalin)
and antidepressants (amitriptyline, imipramine),opiates and in clinical
practice analgesics, NSAIDs or corticosteroids are also used to relieve
neuropathy pain.
Diabetes and its complications are major causes of mortality, morbidity and
poor quality of life. Long term use of anti-convulsant and
anti-depressants produce many side effects- nausea, increased appetite, weight
gain, loss of libido, erectile dysfunction, fatigue, drowsiness, insomnia, dry
mouth, constipation, dizziness, agitation, irritability, etc. Anxiety, liver
damage, brain damage due to hypoxia resulting from respiratory depression,
development of tolerance and dependence on opiates. In Ayurvedic classicals
there is no disease which can be correlated with DN, however detailed
description of Prameha and its Upadrava available in classical treatises can
help in understanding DN from Ayurveda’s perspective. Symptoms mentioned in
Purvarupa and Upadrava of Prameha and Madhumeha show close resemblance with
signs and symptoms of DN. Recent researches in Ayurveda have proved efficacy of
various herbal and Herbomineral drugs in Diabetic Neuropathy. Ayurvedic
medicines such as Ashwagandha, Amalki, Guduchi, Shilajatu etc. evaluated through different
preclinical or clinical studies. But still effective treatment is not available
even on long term use of Ayurvedic or conventional management. |