| CTRI Number |
CTRI/2022/11/047342 [Registered on: 16/11/2022] Trial Registered Prospectively |
| Last Modified On: |
11/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Vatantak Gold Tablet and Pain Kill Oil in painful inflammatory Musculoskeletal Conditions |
|
Scientific Title of Study
|
Post-marketing open-label observational clinical study of Vatantak Gold Tablet and Pain Kill Oil in painful inflammatory Musculoskeletal Conditions w.r.t Vatavyadhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PARIKSHIT DEBNATH |
| Designation |
Chief Physician |
| Affiliation |
Gananath Sen Institute of Ayurvidya and Research |
| Address |
Dept. of Ayurveda
64/98B/1 Belgachia Road
Kolkata
WEST BENGAL
700037
India |
| Phone |
9836675720 |
| Fax |
|
| Email |
docdebnath84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PARIKSHIT DEBNATH |
| Designation |
Chief Physician |
| Affiliation |
Gananath Sen Institute of Ayurvidya and Research |
| Address |
Dept. of Ayurveda
64/98B/1 Belgachia Road
Kolkata
WEST BENGAL
700037
India |
| Phone |
9836675720 |
| Fax |
|
| Email |
docdebnath84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PARIKSHIT DEBNATH |
| Designation |
Chief Physician |
| Affiliation |
Gananath Sen Institute of Ayurvidya and Research |
| Address |
Dept. of Ayurveda
Kolkata
WEST BENGAL
700037
India |
| Phone |
9836675720 |
| Fax |
|
| Email |
docdebnath84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamna Herbal Research Limited.
E-5, New Industrial Area, Mandideep, MP - 462046 |
|
|
Primary Sponsor
|
| Name |
Med Pharma CRO |
| Address |
119, Rajdanga Gold Park, Kolkata – 700107 |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jamna Herbal Research Limited |
E-5, New Industrial Area, Mandideep, MP - 462046 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parikshit Debnath |
Gananath Sen Institute of Ayurvidya and Research |
Dept. of Ayurveda.
64/98B/1 Belgachia Road, Kolkata - 700 037
Kolkata
WEST BENGAL |
9836675720
docdebnath84@gmail.com |
| DrParikshit Debnath |
The Ayurveda Clinic and Research Centre |
Dept. of Ayurveda.
119, Rajdanga Gold Park, Kolkata - 700107
Kolkata
WEST BENGAL |
9836675720
docdebnath84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee (Clinical Research) India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pain Kill Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 4(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Vatantak Gold Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk or Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients 18 years or older, with musculoskeletal pain.
2.Patients willing to give written informed consent.
3.Patients are fit and no need for any hospital administration.
4.Agree to following instruction of do’s and don’ts in regular daily lifestyle.
5.Patients willing to perform all study related procedures including the use of study medicine, allow the physical and Biochemical tests and willing to document symptoms and medication.
|
|
| ExclusionCriteria |
| Details |
1.Use of steroids and/or recreational drugs in the past 6 months.
2.Patients with open wounds or infection at the application site.
3.Patients with renal impairment.
4.Patients will be also excluded if they have poorly controlled diabetes mellitus.
5.Female patients who are pregnant.
6.Unstable medical or psychiatric illness.
7.Chronic & acute disorders requiring hospital admission.
8.Known HIV-positive, Hepatitis B or C status.
9.Inability to carry out visits for the study.
10.Inability to maintain current medication regimen.
11.Inability or unwillingness to participate in all components of the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain Score (VAS and NPRS)
2.Disease activity based on questionnaires(QoL)
3.Blood tests: ESR, RA factor, CRP, Serum Uric Acid
(At baseline and after 60 days of treatment)
|
At baseline and after 60 days of treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Quality of Life
2. Drug safety: RFT & LFT
3. Incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period
(From Baseline to 60 days of treatment)
|
From Baseline to 60 days of treatment |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
19/11/2022 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet.
To be published in peer reviewed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - o gain access, data requestors will need to sign a data access agreement. Then Data will be made available privately.
- For how long will this data be available start date provided 01-07-2023 and end date provided 30-06-2026?
Response (Others) - As per request. But not later than 3 years of study completion
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Post-marketing open labelobservational clinical study will be undertaken under investigator and his team in Kolkata at 2 sites. Total no. of study patients 60+10% dropouts. Only those patients providing written informed consent will be enrolled for the study in specific study centre. After receiving the written consent, all patients will be assessed according to inclusion and exclusion criteria, and then will be enrolled. Study materials will be provided to them free of cost for their regular use, along with specific information. Patients need to apply locally Pain Kill Oil twice daily and oral intake of Vatantak Gold Tablet - 2 tablet twice daily before food with milk or lukewarm water for 60 days. Diet habit/ life style modification will also be guided. The patients will visit their specific centre at baseline and at end of the study for assessment. Statistical analysis will be done according to type of data and significance will be considered p= less than 0.05. |