| CTRI Number |
CTRI/2024/04/065793 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
It is a single arm clinical study to see the efficacy of Darvyadi Kwath drug (Ayurvedic formulation)in patients suffering from neuropathic symptoms caused due to chronocity of Diabetes Mellitus disease.
|
|
Scientific Title of Study
|
A Single Arm clinical study to evaluate the efficacy of Darvyadi Kwath in Diabetic Polyneuropathy. |
| 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. Swapnil Balasaheb Kedar |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurved and Research Centre |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9168448887 |
| Fax |
|
| Email |
swapnilkedar0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Shekhar |
| Designation |
Assiciate Professor and Phd Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9168448887 |
| Fax |
|
| Email |
abhijitshekhar00@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit Shekhar |
| Designation |
Associates Professor and Phd Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9168448887 |
| Fax |
|
| Email |
abhijitshekhar00@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune,
Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Swapnil Balasaheb Kedar |
| Address |
Dr D Y Patil College of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018 |
| Type of Sponsor |
Other [SELF] |
|
|
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 SWAPNIL BALASAHEB KEDAR |
Dr D Y Patil College Of Ayurved and Research Centre |
kayachikitsa department,5 no opd ,Dr D Y patil college of Ayurved and Research Centre,pimpri pune
Pune
MAHARASHTRA |
09168448887
swapnilkedar0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA and RC Institutional Ethical 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: Darvyadi Kwath, Reference: Charak Chikitsa chapter no 6 Prameha shlok 26th, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Darvyadi Kwath will be given to the patient of Diabetic Polyneuropathy. |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
A known Diabetic on treatment.
Patient who are not taking any medications for Diabetic Polyneuropathy And having symptoms of Diabetic Polyneuropathy
|
|
| ExclusionCriteria |
| Details |
1. Pregnant lactating women.
2. Patients with pulmonary tuberculosis, cardiac complications, Renal complications, sciatica, cord compression, Immunocompromised patients, malignancies.
3. Vitamin B12 deficiency. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of Darvyadi Kwath will be assessed over the 28 days by objective parameters. |
28 Days study.
Follow up on 14th and 28th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Distal Symmetric Polyneuropathy in Diabetes under the subjective
measurement of Toronto Clinical scoring scale. |
28 Days study.
Follow up on 14th & 28th day. |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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 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
|
TO STUDY EFFECT OF DARVYADI KWATH GIVEN 40 ML TWICE A DAY ORALLY ON 30 PATIENTS WHO HAVING SYMPTOMS OF DIABETIC POLYNEUROPATHY I.E. TINGLING SENSATION,BURNING SENSATION,PAIN,NUMBNESS ETC WITHIN 28 DAYS WITH TWO FOLLOW UPSDUE TO CHRONIC ILLNESS OF DIABETES MELLITUS.FINAL CONCLUSION WILL BE DRAWN ON THE BASIS OF STATISTICAL METHODS. |