| CTRI Number |
CTRI/2025/05/087750 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management of Eczema with the help of Visha Tailam and Amruta Guggulu. |
|
Scientific Title of Study
|
Efficacy of Amruta Guggulu orally and Visha Tailam topically in the management
of Vicharchika w.s.r to Eczema in age group from 18 -70 years (RCT).
|
| 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 Sangita Govindrao Bhange |
| Designation |
PG Scholar |
| Affiliation |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated
with L.K ayurved rugnalaya yavatmal Department of kayachikista
Ground floor Opd no : 10
Yavatmal
MAHARASHTRA
445001
India
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9766056191 |
| Fax |
|
| Email |
dr.sangitabhange18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh P Duddalwar |
| Designation |
Associate Professor |
| Affiliation |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal
Department of kayachikista Ground floor Opd no 10
Yavatmal
MAHARASHTRA
445001
India
with L.K ayurved rugnalaya yavatmal Department of kayachikista
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9423624476 |
| Fax |
|
| Email |
dr.yogesh.duddalwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh P Duddalwar |
| Designation |
Associate Professor |
| Affiliation |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal
Department of kayachikista Ground floor Opd no 10
Yavatmal
MAHARASHTRA
445001
India
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9423624476 |
| Fax |
|
| Email |
dr.yogesh.duddalwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMM ayurved Mahavidyalaya afiliated with L.K Ayurved rugnalaya Shivaji nagar Arni road
yavatmal, 445001 |
|
|
Primary Sponsor
|
| Name |
DMM ayurved Mahavidyalaya Yavtmal |
| Address |
Department of Kayachikitsa, DMM ayurved Mahavidyalaya,shivaji
nagar, arni road, Yavatmal,Maharashtra,India 445001 |
| 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 Sangita Govindrao Bhange |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated
with L.K ayurved rugnalaya yavatmal Department of kayachikista
Ground floor Opd no : 10
Yavatmal
MAHARASHTRA
445001
India
Yavatmal
MAHARASHTRA |
09766056191
dr.sangitabhange18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L20-L30||Dermatitis and eczema. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amruta Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -(2) Medicine Name: Vishatailam, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchatikta Ghruta Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: -(2) Medicine Name: Brihat Marichyadi Tailam, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
i. Pateint outcome having clinical signs and symptoms of Vicharchika.
ii. Patient age group from 18 years to 70 years.
iii. Patient irrespective of caste and religion, occupation, gender.
iv. Patient belonging to any socio-economical class. |
|
| ExclusionCriteria |
| Details |
1) Age group below 18 years and above 70 years.
2) Pateint with uncontrolled systemic disorder like Diabetic wound, cardiac disorder,
Leprosy, Tuberculosis, Malignancy, Pregnant Women, Lactating Mother, Scabies
Psoriasis, Fungal Infection will Be excluded.
3) Immune compromised like HIV and Hep B.
4) Patient having cardiac diseases, diabetic foot and gangrene.
5) Renal diseases like CKD. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patients with clinical symptoms of vicharchika as described.
1) Kandu (Itching)
2) Shyava varna (Blackish Discoluration)
3) Pidika (Papules)
4) Rukshata (Dryness)
5) Ruja (Pain)
6) Strava (Discharge) |
0, 7th, 15th, 23th, 30th, 38th, 45th, 60th, 75th, 90th. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Investigations.
1) CBC with DLC
2) ESR
3) BSL
4) HBsAg
5) KFT
6) LFT
|
0, 90th. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/06/2025 |
| 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 Yet Recruiting |
| 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
|
Ayurveda, the ancient Indian system of health science, is a holistic approach to physical, social, and spiritual well-being. It encompasses preventive and curative principles and is recognized as the "science of life." Among its eight branches, Kayachikitsa (general medicine) is the first specialized branch focused on treatment. Skin, being the body’s largest organ, is vulnerable to various disorders such as acne, eczema, scabies, fungal infections, and rashes.Approximately 10–20% of general medical cases involve skin conditions, with eczema being particularly common. In Ayurveda, skin diseases are broadly categorized under Kushtha Roga, a term that encompasses a wide range of dermatological issues. This study highlights the Ayurvedic perspective on skin disorders and their management through the principles of Kayachikitsa. The study involves the use of Amruta Guggulu and Visha Tailam , classical formulations from Bhaishajya Ratnavali, aimed at managing eczema through their traditional therapeutic effect. |