| CTRI Number |
CTRI/2025/09/095476 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Dashang Lepa and Daruharidra Rasanjan Lepa in Acute inflammatory Swelling |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation of Dashang Lepa and Daruharidra Rasanjan
Lepa in Vrana Shopha
(Acute Inflammatory Swelling) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lokesh Kumar Tamta |
| Designation |
PG Scholar (Department of Shalya Tantra) |
| Affiliation |
Quadra Institute of Ayurveda, Roorkee |
| Address |
Department of Shalya Tantra, Quadra Institute of Ayurveda, Roorkee, Haridwar, Uttarakhand, 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
7457097100 |
| Fax |
247667 |
| Email |
drlokeshtamta3030@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjit Singh |
| Designation |
HOD and Professor (Department of Shalya Tantra) |
| Affiliation |
Quadra Institute of Ayurveda, Roorkee |
| Address |
Department of Shalya Tantra, Quadra Institute of Ayurveda, Roorkee, Haridwar, Uttarakhand, 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9461940996 |
| Fax |
|
| Email |
dr.raji83@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Lokesh Kumar Tamta |
| Designation |
PG Scholar (Department of Shalya Tantra) |
| Affiliation |
Quadra Institute of Ayurveda, Roorkee |
| Address |
Department of Shalya Tantra, Quadra Institute of Ayurveda, Roorkee, Haridwar, Uttarakhand, 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
7457097100 |
| Fax |
|
| Email |
drlokeshtamta3030@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Lokesh Kumar Tamta, Department of Shalya Tantra, Quadra Institute of Ayurveda, Roorkee, Haridwar, Uttarakhand, 247667 |
|
|
Primary Sponsor
|
| Name |
Lokesh Kumar Tamta |
| Address |
Quadra Institute of Ayurveda, Roorkee, Haridwar, Uttarakhand, 247667 |
| Type of Sponsor |
Private medical college |
|
|
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 Lokesh Kumar Tamta |
Quadra Institute of Ayurveda and Hospital, Roorkee |
OPD No 1, Department of Shalya Tantra, Quadra Institute of Ayurveda and Hospital, Roorkee, Haridwar, Uttarakhand, 247667
Hardwar
UTTARANCHAL |
7457097100
drlokeshtamta3030@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Quadra Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: VRANASOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Daruharidra Rasanjan, Reference: Dravya Guna Vigyana by Priya Vrata Sharma Vol. 2, p.539, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Local Application Followed by Dressing | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashang Lepa, Reference: Bhavprakash, Uttrardh, Dwitiya Bhag 56/32, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Local Application Followed by Dressing |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Classical Symptom of Vrana shotha. (Twak samvarnta, Ushnata, Vedana, Shoth)
Classical symptoms of Inflammatory Swelling: [Rubor, Calor, Tumor, Dolor, Functio-Laesa]
Age Criteria: 18yrs to 50 Yrs.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Patient below the age of 18 years and above the age of 50 years.
Patient suffering from severe systemic disorders such as HIV, HbSAg, HCV, any hereditary disorder will be excluded from this study.
Patients with uncontrolled DM & HTN
Patient who are not ready to sign written informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective: The assessment of drug trial will be done on the basis of improvement in the symptoms mentioned in inclusion criteria.
1.Vedana/ Pain (Dolor) by Visual Analogue Score
2.Shotha/ Inflammation (Tumor)
3.Usnata/ Temperature (Calor)
4.Functio Laesa by range of motion (ROM)
5.Twak Samvarnata/ Redness (Rubor) by Inspection
|
Assessment on every 5th day i.e. 5th, 10th and 15th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective:
Site in the extremities
Surface- Uneven, Even, Smooth
Size of Vrana Shotha- Less than 2mm, 2-4mm, 4-6mm, 4-6mm, 8mm and above.
|
Assessment on every 5th day i.e. 5th, 10th and 15th day to evaluate the comparative analysis of daruharidra rasanjan lepa and dashang lepa in vrana shopha (Acute Inflammatory Swelling)
1st follow up 7th day after the completion of treatment
2nd follow up 7th day after first follow up
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="6"
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 a
comparative clinical study for the evaluation of Dashang Lepa and Daruharidra
Rasanjan lepa in Vrana Shopha (Acute Inflammatory Swelling), Since Dashang
Lepa is already established drug used in vrana shopha, so studying
management of vrana shopha using Daruharidra Rasanjan lepa can uncover
new knowledge, improve treatments, and ultimately enhance the overall care and
recovery of patients with these conditions, effectiveness of Daruharidra
Rasanjan Lepa as a single drug can be determined in the treatment of vrana
shopha as compared of Dashang Lepa, which already have a better results
in the treatment of the same and outcomes can be measured. For the
present research study total 40 patients are selected for clinical trial. In
this clinical study, Dashang Lepa and Daruharidra Rasanjan lepa in
Vrana Shopha (Acute Inflammatory Swelling) will be done on 20-20 patients
respectively. Patients will be randomly selected with clinical features of vrana
shopha attending the OPD and IPD of Shalya Tantra dept and other dept of Quadra
Hospital irrespective of their gender, race, religion, occupation. This
clinical study will be conducted with aim and objective to provide better, safe
and effective management to the patient of vrana shopha. A detailed Performa
will be prepared on the basis of Ayurvedic text and allied Sciences. The
patient fulfilling the inclusion and exclusion criteria will be registered on
this Performa and scoring of the different clinical features will be done on
the assessment criteria. the observation of the patients will be done before,
during and the after completion of trial. Little addition or exclusion may be
done as per the necessity of the study. |