| CTRI Number |
CTRI/2025/06/088692 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the combined effect of Tablet Swayambhuva guggul and eladi cream in dermatitis in the age group of 18-60 years |
|
Scientific Title of Study
|
An exploratory clinical study to evaluate efficacy of combined effect of swayambhuva guggul tablet and eladi cream in vicharchika (eczema) in the age group of 18-60 years |
| 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 Madhuri Gore |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,1st floor,Agadtantra department ,Sector no 25, Pradhikaran,Nigdi,Pune
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9422891984 |
| Fax |
|
| Email |
goremadhuri08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayant Phadke |
| Designation |
Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,1st floor,Agadtantra department ,Sector no 25, Pradhikaran,Nigdi,Pune
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822615265 |
| Fax |
|
| Email |
jayantphadke10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri Gore |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,1st floor,Agadtantra department ,Sector no 25, Pradhikaran,Nigdi,Pune
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9422891984 |
| Fax |
|
| Email |
goremadhuri08@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre , Nigdi , Pune 411044 Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre , Nigdi , Pune 411044 Maharashtra, India |
| Address |
Sector no 25 Pradhikaran Nigdi Pune 411044 |
| Type of Sponsor |
Private 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 Madhuri Gore |
Ayurved Rugnalaya and Snowbell Multispeciality Hospital |
Vishachikitsa OPD no 117-B Nigdi
Pune,Maharashtra
Pune
MAHARASHTRA |
9422891984
goremadhuri08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Standard Operating Procedure for Institutional Ethical Committee-I for Human Research at Pune District Education Associations College of Ayurved and Research Centre Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: swayambhuva guggul tablet, Reference: Gada Nigraha, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -luck warm water), Additional Information: -(2) Medicine Name: Eladi cream, Reference: Ashtang Hridaya, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0.25(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptoms of vicharchika (Eczema) that is kandu, pidaka,shyavata , bahu srava |
|
| ExclusionCriteria |
| Details |
1)Patients with major systemic disorder and other blood disorders such as haemophilia along with vicharchika
2)pregnant women, lactating women
3)incompatible to guggul seven |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the combined effect of swayambhuva guggul tablet and eladi cream in 14 days in vicharchika (eczema) in age group of 18-60 years |
two times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/06/2025 |
| 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="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
|
In Ayurveda all skin disorders are categorised under Kushtha . Which is further classified in two types, Mahakushtha and
Kshudra Kushtha. Vicharchika (Eczema) is explained by Acharya Charak
in Kshudra kusta. From modern medicine point of view, Vicharchika can be co-related with
eczema, a type of dermatitis or inflammation of the skin’s upper layers.Swayambhuva guggul is a formulation mentioned in Gada Nigraha and Bhava Prakash,Its phalashruti says it is garavishahara ,kushtahara. Eladi gana dravyas are mentioned in Ashtang Hridaya, Shodhanadi gana sangraha, to consist KaphaVataghna, Kushthaghna and vishghna
properties. In order to find combined effect of Swayambhuva guggul tablet and eladi
cream against these above mentioned symptoms developed due to
Vicharchika (Eczema), Swayambhuva guggul tablet and eladi cream are
taken for this study. |