| CTRI Number |
CTRI/2023/02/049994 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study held to see the effect of Dashamooladi tablet in tingling sensation and/or numbness |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the efficacy of Dashamooladi Ghanavati in the management of Jhinjhini Vata (Peripheral Neuropathy) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavya Khurana |
| Designation |
MD 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 |
8800655055 |
| Fax |
|
| Email |
bhavyakhurana1997bk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Digambar Dipankar |
| Designation |
Professor of Department of 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 |
9822279321 |
| Fax |
|
| Email |
drdgdipankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavya Khurana |
| Designation |
MD 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 |
8800655055 |
| Fax |
|
| Email |
bhavyakhurana1997bk@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 Bhavya Khurana |
| 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 Bhavya Khurana |
Dr D Y Patil College Of Ayurved and Research Centre |
OPD No 5 Kayachikitsa Department
Dr D Y Patil College Of Ayurved and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Pune
MAHARASHTRA |
8800655055
bhavyakhurana1997bk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G909||Disorder of the autonomic nervoussystem, unspecified. Ayurveda Condition: JHINJHINI VATA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashamooladi Ghanvati, Reference: Chakradatta 22/61 and Bhaisajya Ratnavali 26/53, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: Follow up on 7th and 14th day. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Age between 18-70 years of both genders.
2) Patients with the symptoms of tingling sensation and/or numbness.
3) Patients who are not taking any other medications for tingling sensations and/or numbness.
|
|
| ExclusionCriteria |
| Details |
1) Known pregnant and lactating woman.
2) Patients with Pulmonary Tuberculosis , Cardiac complications, Immuno-compromised, Renal complications, Malignancies etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access the effect of Dashamooladi Ghanavati in the management of Jhinjhini Vata |
14 days study with 2 follow ups (0,7,14) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the new etiological factors of Jhinjhini Vata in present era.
2) To study the ayurvedic pathogenesis of Jhinjhini Vata. |
14 days study with 2 follow ups (0,7,14) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to see the effectiveness of Dashamooladi Ghanavati in the management of Jhinjhini Vata (Peripheral Neuropathy). The study will be conducted with 30 patients showing signs and symptoms of peripheral neuropathy - tingling sensation and/or numbness. They will be administered 2 tablets (each 500 mg) twice a day along with warm water, for a duration of 14 days. Follow ups will be done on 7th and 14th day. Final conclusion will be drawn on the basis of proper statistical methods. |