| CTRI Number |
CTRI/2024/06/068675 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study To Evaluate The Effect Of Bhavitha Shilajatu In Diabetic Peripheral Neuropathy |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Yashtimadhu Bhavita Shilajatu and Balamoola Bhavita Shilajatu In Diabetic Peripheral 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 Rakesh |
| Designation |
Assistant Professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital |
| Address |
OPD NO-2
Kayachikitsa General
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
B M Road, Thanniruhalla
Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9591838173 |
| Fax |
|
| Email |
rakeshamoolya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mythrey R C |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College, Mysuru |
| Address |
OPD NO 10
Kayachikitsa
Government Ayurveda Medical College
Sayyaji Rao Road,
Mysuru 01
Mysore
KARNATAKA
570001
India |
| Phone |
8618570803 |
| Fax |
|
| Email |
mythreyrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh |
| Designation |
Assistant Professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital |
| Address |
B M Road, Thanniruhalla
Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9591838173 |
| Fax |
|
| Email |
rakeshamoolya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
B M Road Thanniruhalla
Hassan 573201
Karnataka State
India |
|
|
Primary Sponsor
|
| Name |
Dr Rakesh |
| Address |
SDM College of Ayurveda and Hospital
B M Road Thanirruhalla Hassan |
| Type of Sponsor |
Other [individual( self)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh |
Government Ayurveda Medical College |
OPD NO 10
Kayachikitsa
Government Ayurveda Medical College
Sayyaji Rao Road,
Mysuru - 01
Mysore
KARNATAKA |
9591838173
rakeshamoolya@gmail.com |
| Dr Rakesh |
SDM College of Ayurveda and Hospital |
OPD NO 2
Kayachikitsa General
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
B M Road Thanniruhalla
Hassan 573201
Hassan
KARNATAKA |
9591838173
rakeshamoolya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| government ayurveda medical hospital |
Approved |
| SDM COLLEGE OF AYURVEDA AND HOSPITAL |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bala Moola Bhavita Shilajatu, Reference: Sushruta Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu Bhavita Shilajatu, Reference: Sushruta Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Metabolically stable diabetic Subjects with symptomatic Diabetic Peripheral Neuropathy.
Subjects fulfilling the diagnostic criteria.
Subjects whose HbA1c is between 6.5 to 9%.
Subjects of all gender between the age group of 40 - 65 years
|
|
| ExclusionCriteria |
| Details |
Subjects whose HbA1c is more than 9%.
Subjects with other metabolic and endocrinal disorders.
Subjects with other causes of Polyneuropathy.
Subjects suffering from infectious diseases and non healing ulcer/ulcers.
Subjects with cardiac aliments and Nephropathy.
Subjects with Diabetic Neuropathy in stage N3 of Dyck’s staging
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vibration Perception Threshold (VPT) on BIOTHESIOMETER Before and After the Treatment |
1st Assessment – Before Treatment (0th day)
2nd Assessment – During Treatment (31st day)
3rd Assessment – During Treatment (61st day)
4th Assessment – After Treatment (91st day)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Diabetic Neuropathy Symptom (DNS) questionnaire Score Before and After the Treatment
Diabetic Neuropathy Examination Score (DNE) Before and After the Treatment
Visual Analog Scale (VAS) Before and After the Treatment
WHO Quality of Life (WHO QoL) BREF Before and After the Treatment
|
1st Assessment – Before Treatment (0th day)
2nd Assessment – During Treatment (31st day)
3rd Assessment – During Treatment (61st day)
4th Assessment – After Treatment (91st day) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aim of this study is to compare the effects of yashtimadhu bhavita shilajitu and balamoola bhavita shialajitu in diabetic peripheral neuropathy. 200 subjects satisfying diagnostic and inclusion criteria will be divided into 2 groups of 100 subjects each. Intervention will be given for 8 weeks. Post 8 weeks of intervention, the subjects will be assessed for changes in vibration perception threshold, diabetic neuropathy symptom questionnaire, diabetic neuropathy examination score, visual analogue scale and WHO quality of life. |