| CTRI Number |
CTRI/2025/05/087024 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Process of Care Changes
Other (Specify) [on improvement of signs and symptoms] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Physicochemical and Radomized Controlled Clinical Study Of Padmaka (Prunus cerasoides D.DON) As Vedanasthapaka In Supti (NUMBNESS) W.S.R.To Diabetic Neoropathy. |
|
Scientific Title of Study
|
A PHYSICOCHEMICAL AND RANDOMIZED CONTROLLED CLINICAL STUDY OF PADMAKA (Prunus cerasoides D. DON) AS VEDANASTHAK IN SUPTI (NUMBNESS) W.S.R.TO DIABETIC NEUROPATHY. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashashri Tulsiram Shinde |
| Designation |
Professor |
| Affiliation |
Yashwantrao Chavan Ayurvedic Medical College and Hospital |
| Address |
Block no 7,Department of Dravyaguna, Yahswantrao Chavan Ayurvedic Medical College and Hospital, Nipani , Bhalgaon, Chh.Sambhajinagar
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
7814944559 |
| Fax |
|
| Email |
ashashri2011@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay R. Talmale |
| Designation |
Associate Professor |
| Affiliation |
Govt. Ayurved College, Nagpur |
| Address |
Block no 5,Department of Dravyaguna, Govt Ayurved College, Kamla Nehru Road, Sakkardara Chowk, Raje Raghuji Nagar, Ayurvedic Layout, Nagpur, Maharashtra 440009
Block no 5,Department of Dravyaguna, Govt Ayurved College, Kamla Nehru Road, Sakkardara Chowk, Raje Raghuji Nagar, Ayurvedic Layout, Nagpur, Maharashtra 440009
Aurangabad
MAHARASHTRA
440009
India |
| Phone |
9423340001 |
| Fax |
|
| Email |
drsanjayleela@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashashri Tulsiram Shinde |
| Designation |
Professor |
| Affiliation |
Yashwantrao Chavan Ayurvedic Medical College and Hospital |
| Address |
Block no 7,Department of Dravyaguna, Yahswantrao Chavan Ayurvedic Medical College and Hospital, Nipani , Bhalgaon, Chh.Sambhajinagar
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
7814944559 |
| Fax |
|
| Email |
ashashri2011@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwantrao Chavan Ayurvedic Medical College and Hospital, Near Videocon , Nipani -Bhalgaon, Chh.Sambhajinagar ,Maharashtra, India, 431007, |
|
|
Primary Sponsor
|
| Name |
Dr Ashashri Tulsiram Shinde |
| Address |
block no 7,Department of Dravyaguna, Yahswantrao Chavan Ayurvedic Medical College and Hospital, Nipani , Bhalgaon, Chh.Sambhajinagar |
| Type of Sponsor |
Other [Primary Investigator] |
|
|
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 Ashashri Tulsiram Shinde |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College |
block no 7,Department of Dravyaguna, Yahswantrao Chavan Ayurvedic Medical College and Hospital, Nipani , Bhalgaon, Chh.Sambhajinagar
Aurangabad
MAHARASHTRA |
7814944559
ashashri2011@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| R.A. Podar Ayurved College, Worli, Mumbai |
Approved |
| Yashwantrao Chavan Ayurvedic Medical COllege 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: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Conventional treatment | Conventional treatment in the form of tablet Pregabalin (75mg) and Methylcobalamin (1500mcg) OD. for 3 months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Padmak, Reference: Charaka Sutrasthana Adhyay Chapter 4, Shloka no 47, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject willing to give written informed consent.2.Patients ready to comply trial protocol.
3.Both gender with Age between 30-70 years. 4.Patients diagnosed with Type 2 diabetes mellitus with evidence of clinical, symptomatic, symmetric, distal neuropathy with numbness. 5.Patients with atleast 7-8 years of duration of diabetes
|
|
| ExclusionCriteria |
| Details |
1.Subjects not willing to give written informed consent. 2.Age below 30 and above 70 years 3.K/C/O of Leprosy, gangrene or where permanent nerve damage occurs. HIV, or any other debelating disorders. 4.Patients who are not ready to comply the trial protocols. 5.Those with any neuropathy other than diabetic neuropathy. 6.Patients with Peripheral vascular disease. 7.Those on antidepressants, opiates, anticonvulsant, capsaicin and also an aldose deductase inhibitors.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study physicochemical properties and clinical efficacy of Padmak (Prunus cerasoides D. DON) as Vedanasthapak (establish densation at sensrless sight) in supti (numbness) w.s.r to diabetic neuropathy.
• To see effect of Padmak as Vedanasthapak in Supti w.s.r to numbness in Diabetic neuropathy.
• To analyse pharmacognostic and physicochemical properties of Padmak.
• To co-relate Supti with diabetic neuropathy.
|
baseline and after every 15 days upto 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To see effect of Padmak as Vedanasthapak in Supti w.s.r to numbness in Diabetic neuropathy.
|
6 months |
| • To analyse pharmacognostic and physicochemical properties of Padmak. |
1 month |
| •To co-relate Supti with diabetic neuropathy. |
10 days |
|
|
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)
|
19/05/2025 |
| 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="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is open parallel labelled , randomized , interventional , clinical controlled study, in which patients are grouped into 2, one is trial group in which 30 patients will be included for study they will recieve Padmak choorna in the dose of 1.5gm BD in Pragbhatka kala for 3 months and another controlled group will recieve Pregabalin 75mg with methylcobalamin 1500mcg OD for 3 months, primary focus of the clinical trial is to study physicochemical inmportantc and vedanasthak in supti that is numbness in diabetic neuropathy along with study on Tingling sensation (Hastapaad chimchamayan) and Burning Sensation (Hasta Paad tal daha) also, for objective study assesment will be done with the heko of filament test |