| CTRI Number |
CTRI/2026/06/111601 [Registered on: 01/06/2026] Trial Registered Prospectively |
| Last Modified On: |
30/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the Effect of Durvadi Oil in the Treatment of Eczema (Vicharchika). |
|
Scientific Title of Study
|
A pharmaco-clinical study to evaluate the effectiveness of Durvadi Tail (Cynodon dactylon(l.)pers.) in the management of Vicharchika w.s.r. to Eczematous Dermatoses |
| 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 Aakriti |
| Designation |
MD SCHOLAR |
| Affiliation |
State Ayurvedic College and Hospital,Lucknow |
| Address |
Post Graduate Department of Dravyaguna,State Ayurvedic College and Hospital,Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
6392679782 |
| Fax |
0 |
| Email |
rpaakriti15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramanand |
| Designation |
Lecturer |
| Affiliation |
State Ayurvedic College and Hospital,Lucknow |
| Address |
Post Graduate Department of Dravyaguna,State Ayurvedic College and Hospital,Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9415593858 |
| Fax |
0 |
| Email |
dr.ramanand72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramanand |
| Designation |
Lecturer |
| Affiliation |
State Ayurvedic College and Hospital,Lucknow |
| Address |
Post Graduate Department of Dravyaguna,State Ayurvedic College and Hospital,Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9415593858 |
| Fax |
0 |
| Email |
dr.ramanand72@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital,Tulsidas Marg, Turiyaganj, Lucknow, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital,Lucknow |
| Address |
State Ayurvedic College and Hospital,Tulsidas Marg, Turiyaganj, Lucknow, Uttar Pradesh |
| Type of Sponsor |
Government 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 Aakriti |
State Ayurvedic College and Hospital,Lucknow |
OPD No.08 P.G.Department of Dravyaguna ,State Ayurvedic College and Hospital Tulsidas Marg Old Haidarganj Turiyaganj,Lucknow,Uttar Pradesh 226004 India
Lucknow
UTTAR PRADESH |
6392679782
rpaakriti15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individual without any illness or systemic disease |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DURVADI TAIL, Reference: CHAKRADUTTA, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Clobetasone propionate cream USP 0.05% , Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -Clobetasone propionate cream USP 0.05% |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1- Age group: Between 18 to 70 years.
2- The patients with classical lakshana(s) of Vicharchika irrespective of chronicity will be selected.
3- Both new and chronic cases of Vicharchika w.s.r. to ECZEMATOUS DERMATOSES will be treated, and
4- Patients willing to participate in above mentioned trial. |
|
| ExclusionCriteria |
| Details |
1- Age group: Less than 18 years and more than 70 years
2- Any sensitivity reaction to the preparation
3- Skin cancer, psoriasis, etc associated with fungal infection
4- Pregnant and lactating women
5- Diabetics and immune compromised people.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Durvadi Tail in the management of Vicharchika with special reference to Eczematous Dermatoses. |
Patient
enrolled in this group will be evaluated for the outcomes after 2 month of the
therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To examine the drug of sample DURVA for the pharmacognostical
properties & comparing it with the standard sample given in API. |
Patient
enrolled in this group will be evaluated for the outcomes after 2 month of the
therapy. |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/06/2026 |
| 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="8"
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 the Randomised, comparative clinical study Phase 2 Parellel group trial. Comparing the efficacy of Durvadi Tail and Clobetasol Propionate Ointment in the management of Vicharchika with special reference to Eczematous Dermatoses for 2 months in 60 patients. The patient fulfilling the clinical criteria for diagnosis of Vicharchika will be randomly selected form OPD and IPD of State Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history taking, physical examination and necessary investigations will be performed. Further patient divided into two groups,Group A-In this group patient will be treated with Clobetasol Propionate Ointment for local application for 2 months twice in a day. Group B-In this group patient will be treated with Durvadi Tail for local application for 2 months twice in a day.Follow up period will be 15 days after the completion of trail. |