| CTRI Number |
CTRI/2025/08/092258 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of two drugs mesharoma mashyadi taila varti and jatyadi taila varti in patients with nadi vrana ie sinus |
|
Scientific Title of Study
|
A Clinical comparative study on the efficacy of Meshroma Mashyadi Taila Varti and Jatyadi Taila Varti in the management of Nadi vrana w.s.r. to Sinus. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabudh kumar Praveen |
| Designation |
Reader |
| Affiliation |
Dayanand Ayurvedic Medical college and Hospital |
| Address |
Dayanand Ayurvedic Medical college and Hospital Siwan
Rasid Chak Paigamberpur Andar road Siwan Bihar
Siwan
BIHAR
841226
India |
| Phone |
7903765393 |
| Fax |
|
| Email |
pk97713@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prabudh kumar Praveen |
| Designation |
Reader |
| Affiliation |
Dayanand Ayurvedic Medical college and Hospital Siwan |
| Address |
Dayanand Ayurvedic Medical college and Hospital Siwan
Rasid Chak Paigamberpur Andar road Siwan Bihar
BIHAR
841226
India |
| Phone |
7903765393 |
| Fax |
|
| Email |
pk97713@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabudh kumar Praveen |
| Designation |
Reader |
| Affiliation |
Dayanand Ayurvedic Medical college and Hospital |
| Address |
Dayanand Ayurvedic Medical college and Hospital, Siwan
Rasid Chak, Paigamberpur, Andar road, Siwan, Bihar
BIHAR
841226
India |
| Phone |
7903765393 |
| Fax |
|
| Email |
pk97713@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prabudh Kumar Praveen |
| Address |
Dayanand Ayurvedic medical college and Hospital, Rasid chak, paigamberpur, Andar road, Siwan, Bihar |
| Type of Sponsor |
Other [individual ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prabudh Kumar Praveen |
Dayanand Ayurvedic Medical College and Hospital Siwan |
Dayanand Ayurvedic Medical College and Hospital Siwan
Near DAV more
Siwan
BIHAR |
7903765393
pk97713@gmail.com |
| Prabudh Kumar Praveen |
Dayanand Ayurvedic Medical College and Hospital Siwan |
Dayanand Ayurvedic Medical College and Hospital Siwan Department of Shalya Tantra
Siwan
BIHAR |
7903765393
pk97713@gmail.com |
| Prabudh Kumar Praveen |
Dayanand Ayurvedic Medical College and Hospital Siwan |
Dayanand Ayurvedic Medical College and Hospital Siwan Department of Shalya Tantra
Siwan
BIHAR |
7903765393
pk97713@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICAL COMMITTEE, SWAMINARAYAN UNIVERSITY, KALOL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: NADIVRANAH, (2) ICD-10 Condition:L059||Pilonidal cyst and sinus without abscess. Ayurveda Condition: NADIVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | vartiH, वर्तिः Pradhan Karma | (Procedure Reference: Bhav Prakash, Procedure details: Every 3rd day up to 30 days or tract healed)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Nadi vrana
Sinus tract less than 5 centimeters |
|
| ExclusionCriteria |
| Details |
Patients having diabetes mellitus, neoplastic Sinus,actinomycosis, tuberculosis, H.I.V, Hepatitis, CA, Major systemic illness, Hypertension, Anaemia (Hb less than 8mg/dl.
Sinus with more than two opening.
Length of Sinus tract more than 5 cms. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The clinical efficacy of Mesha Roma mashyadiTaila varti will reduced the sign and symptoms of Nadi Varana in 30 days |
The clinical efficacy of Mesha Roma mashyadiTaila varti will reduced the sign and symptoms of Nadi Varana in 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nill |
Nill |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="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 study is randomized single blind parallel group in Dayanand Ayurvedic Medical College and Hospital Siwan Trial comparing the clinical efficacy of Mesha Roma Mashyadi Taila Varti and Jatyadi Taila Varti on every 3rd day upto 30 days or till the tract heal 100 patients with sign and symptoms of Nadi Vrana will be conducted in Dayanand Ayurvedic Medical College and Hospital Siwan India The primary outcome measures will be on the basis of clinical efficacy of sign and symptoms of Nadi vrana in 30 days and assess parameters every 3rd day upto to 30 days or tract will be healed |