| CTRI Number |
CTRI/2024/11/076833 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Pharmaceutical-Clinical Study of Kandughna Mahakashaya In Two Different Dosage Form And Its Effect In Eczema |
|
Scientific Title of Study
|
A Comparative Pharmaceutical And Clinical Study Of Kandughna Mahakashaya Vati And Taila And Their Effect On Vicharchika With Special Reference To Eczema |
| 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 Sandeep Kumar |
| Designation |
M D Scholar Rasa Shastra And Bhaishajya Kalpana |
| Affiliation |
Government P.G Ayurvedic College And Hospital |
| Address |
Government P.G Ayurvedic College And Hospital, Varanasi
Government P.G Ayurvedic College And Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6394032126 |
| Fax |
|
| Email |
sandeep980056@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parwez Ahmad Ansari |
| Designation |
Lecturer |
| Affiliation |
Government P.G Ayurvedic College And Hospital |
| Address |
Government P.G Ayurvedic College And Hospital, Varanasi
Government P.G Ayurvedic College And Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8081373553 |
| Fax |
|
| Email |
drpaansari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kumar Rai |
| Designation |
Reader |
| Affiliation |
Government P.G Ayurvedic College And Hospital |
| Address |
Government P.G Ayurvedic College And Hospital, Varanasi
Government P.G Ayurvedic College And Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8840091930 |
| Fax |
|
| Email |
raivijay07@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Rasashashtra Evam Bhaishajya Kalpana Government P.G. Ayurvedic College And Hospital, Varanasi,Uttar Pradesh,221002 |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurvedic College And Hospital |
| Address |
Department of Rasa Shastra And Bhaishajya Kalpana, Government P.G. Ayurvedic College And Hospital, Varanasi , Uttar Pradesh221002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sandeep Kumar |
Government P.G. Ayurvedic College And Hospital |
Department of Rasashashtra And Bhaishajya Kalpana
OPD no. 5
Varanasi
UTTAR PRADESH |
6394032126
sandeep980056@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government P.G. Ayurvedic College And Hospital, Varanasi, U.P. Mahayogi Guru Gorakhnath Ayush University, Gorakhpur, U.P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L239||Allergic contact dermatitis, unspecified cause. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: kandughna mahakashaya vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: kandughna mahakashaya taila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: kandughna mahakashay vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -(2) Medicine Name: kandughna mahakashaya taila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with sign and symptoms of Vicharchika (Eczema) like Kandu (Itching), Pidika (Papules), Shyava (Blackish discolouration), Srava (Oozing), Rajyo (Disintegrity of skin), Ruja (Pain), Rukshta (Dryness) are selected for study.
Patients having history with of one month or less than one months of origin of Vicharchika (Eczema). |
|
| ExclusionCriteria |
| Details |
Patients having age group of less than 16 years and above 60 years.
Patients with any systemic disorders like uncontrolled hypertension, diabetes mellitus, hypothyroidism/hyperthyroidism and Pregnant & Lactating women.
Patients who are using corticosteroid since long term.
Patients of status Eczematous condition.
Patients of Vicharchika (Eczema) having other skin disorder. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Eczematous Lesions and Itching |
7 Days,14 Days,21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete Relief In Eczematous Lesions And Itching |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "93"
Final Enrollment numbers achieved (India)="93" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| Date of Study Completion (India) |
20/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is an interventional study comparing the efficacy of Kandughna mahakashaya in two different dosage forms. Patients will be randomly selected from the OPD of the Department of Rasa Shastra and Bhaishajya Kalpana and Swasthavritta at Government Ayurveda College and Hospital, Varanasi. 93 patients will be studied under 3 group having 31 patients in each group.
Group A- 31 Patients will be treated with Kandughna mahakashaya Vati for 28 days. Group B- 31 Patients will be treated with Kandughna mahakashaya Taila for 28 days. Group C- 31 Patients will be treated with Kandughna mahakashaya Vati and Taila for 28 days.
Follow-up will be done after 07 days of treatment in each group. The total duration of the treatment plan is 28 days. |