| CTRI Number |
CTRI/2024/12/078223 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Trial To Evaluate The Efficacy Of Chandrasakaladi Vatak And Kandwadau Lepa Churna In The Management Of Dadru |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Chandrasakaladi Vatak And Kandwadau Lepa Churna In The Management Of Dadru |
| 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 Yashmine khan |
| Designation |
PG Scholar |
| Affiliation |
Govt. Ayurvedic College and Hospital Ghy -14 |
| Address |
Dept.of Kayachikitsa ,Govt. Ayurvedic College and Hospital , Jalukbari , Guwahati -14
Kamrup - Assam , India
Kamrup
ASSAM
781014
India |
| Phone |
8600999386 |
| Fax |
|
| Email |
yashmineikhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamanta Kalita |
| Designation |
HoD, Associate Professor and Co- guide |
| Affiliation |
Govt. Ayurvedic College and Hospital, Ghy-14 |
| Address |
Dept. Of Kayachikitsa , Govt. Ayurvedic College and Hospital Jalukbari ,Guwahati-14
Kamrup - Assam , India
Kamrup
ASSAM
781014
India |
| Phone |
9707186463 |
| Fax |
|
| Email |
kalitashyamanta108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShyamanta Kalita |
| Designation |
HoD , Associate Professor and Co-guide |
| Affiliation |
Govt. Ayurvedic College and Hospital, Ghy-14 |
| Address |
Dept Of Kayachikitsa, Govt. Ayurvedic College and Hospital Jalukbari, Guwahati-14
Kamrup -Assam ,India
Kamrup
ASSAM
781014
India |
| Phone |
9707186463 |
| Fax |
|
| Email |
kalitashyamanta108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Ayurvedic College and Hospital Jalukbari Guwahati-14 |
|
|
Primary Sponsor
|
| Name |
DrYashmine Khan |
| Address |
Dept of Kayachikitsa, Govt. Ayurvedic College and Hospital Jalukbari Guwahati-14 |
| Type of Sponsor |
Other [Self] |
|
|
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 Yashmine khan |
Govt. Ayurvedic College and Hospital Jalukbari Guwahati-14 |
OPD and IPD of Dept of Kayachikitsa, Govt. Ayurvedic College and Hospital Jalukbari Guwahati-14
Kamrup
ASSAM |
8600999386
yashmineikhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Govt Ayurvedic College and Hospital, Jalukbari, Guwahati |
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: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kandwadau lepa churna , Reference: Sharangdhar Samhita , Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: To be applied locally with sarsapa taila twice daily and wash off once dry. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandrasakaladi Vatak , Reference: Ashtang Hridaya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: Two vataka thrice a day after meals with water. | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chandrasakaladi Vatak , Reference: Ashtang Hridaya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: Two Vatak thrice a day after meals with water(2) Medicine Name: Kandwadau lepa churna , Reference: Sharangdhar Samhita , Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: To be applied locally with sarsapa taila twice daily and wash off once dry. |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.The Patients with classical symptoms of dadru ( raga,kandu, pidika,unnata mandala)
2.Patients of either sex 16 years to 70 years
3.Diagnosed cases of Tinea.corporis, Tinea.cruris, Tinea. fasceie, Tinea.barbae as symptoms closely relate to dadru.
4. Direct microscopy (10%KOH) skin test positive.
5.Patients having mild to moderate distribution of leison, size of mandala five to ten centimeter , number of mandala four to six ,pidika less than ten.
6.Patients willing to participate in the study and sign the consent form. |
|
| ExclusionCriteria |
| Details |
1.Pregnant / lactating women
2. Tinea associated with other skin disorders to be excluded .
3. Extensive widespread cases will be excluded.
4. Patients suffering from systemic disorders like uncontrolled diabetes, hypertension, on steroid therapy , immunocompromised condition ,autoimmune disorders which interfere with the course of treatment will be excluded.
5.Cases of Tinea mannum , Tinea Pedia, Tinea. Unguim , Tinea capitis will be excluded .
Patients exhibiting hypersensitivity reaction to the trial drug . |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Chandrasakaladi Vatak in the management of symptomatology of dadru.
To also assess the efficacy Of kandwadau lepa churna in the management of symptomatology of dadru .
To assess combined efficacy of Chandrasakaladi Vatak and Kandwadau lepa churna in the management of symptomatology of dadru. |
Day 7, day 14, day 21 ,day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess for the reoccurence of symptoms of dadru . |
At end of 8 week |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
27/12/2024 |
| 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="0"
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 clinical study to assess the efficacy Of Chandrasakaladi Vatak and Kandwadau lepa churna in the management of symptomatology of dadru ( superficial fungal infection) and observe for its reoccurence . This study is done as a mandatory Post graduation thesis work .Total number of patients will be 90 to be studied for 8 weeks. |