| CTRI Number |
CTRI/2024/10/075358 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Abrak Yoga on Silicosis |
|
Scientific Title of Study
|
Physico Chemical Biological Characterization and Exploratory clinical trial of
Abhrak Kalpa in the management of Silicosis |
| 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 Ravi Pratap Singh |
| Designation |
Assistant Professor |
| Affiliation |
PGIA, DSRRAU, Jodhpur |
| Address |
Post Graduate Institute of Ayurved, DSRRAU Campus,
Nagaur Road, Karwar,
Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7229806929 |
| Fax |
|
| Email |
singhravipratap276@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Pradeep Kumar Prajapati |
| Designation |
Vice Chancellor |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
Vice Chancellor office, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,
Nagaur Road, Karwar,
Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9818575845 |
| Fax |
|
| Email |
prajapati.pradeep1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Pradeep Kumar Prajapati |
| Designation |
Vice Chancellor |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
Vice Chancellor Office, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,
Nagaur Road, Karwar,
Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9818575845 |
| Fax |
|
| Email |
prajapati.pradeep1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Nagaur road, Jodhpur |
| Indian Institute of Technology (IIT), Jodhpur |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved, Jodhpur, Rajasthan |
| Address |
PGIA, Dr S R Rajasthan Ayurved University, Jodhpur, Rajasthan 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ravi Pratap Singh |
Near Mandore Garden, Mandore, Jodhpur, Rajasthan
Pincode - 342304 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Pratap Singh |
Sanjeevani Hospital |
Room no. 10 PGIA, Dr S R Rajasthan Ayurved University
Jodhpur
Jodhpur
RAJASTHAN |
7229806929
singhravipratap276@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Post Graduate Institutional Committee,Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J628||Pneumoconiosis due to other dust containing silica. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhrak Kalpa, Reference: Rasa Tarangini, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu or Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients aged between 20-50 years of either sex presenting with clinical features of Swasa roga
having an occupational history of silicosis.
b) Pre-diagnosed silicosis patient.
c) Patient willing to sign a consent form. |
|
| ExclusionCriteria |
| Details |
a) Age below 20 and above 50 years.
b) Patients suffering from tuberculosis.
c) Chronic systemic illness like Carcinoma etc.
d) Patient having Major Renal or Liver disorders.
e) Mentally challenged individuals. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in subjective & objective parameters for silicosis |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in the quality of life of the patients. |
30 days |
|
|
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)
|
15/07/2025 |
| 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="0"
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
|
It is generally accepted that the pathogenesis of pulmonary fibrosis is characterized by persistent
micro-damage to the alveolar epithelium with an abnormal repair process. This process is
characterized by abnormal activation of myofibroblasts, excessive accumulation of ECM, and
lung scar formation, ultimately leading to structural destruction and loss of lung function. [xv]
Ayurveda prescribes a holistic approach to treating the disease or syndrome. Bioactive fractions
from medicinal plants that treat multiple diseases could exert their effects by targeting common
pathways. Hence, a definitive need is to introduce traditional formulation to combat silicosis,
associated disorders, or the probable links with diseases. Silicosis has a complex disease; it is very
tough to correlate with a single disorder in Ayurveda literature. |