| CTRI Number |
CTRI/2023/05/052578 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Nishadi Kwatha And Khadirashtaka Kwatha in eczema |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of Nishadi Kwatha And Khadirashtaka Kwatha in the management of Vicharchika |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Manohar Mokashi |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya |
| Address |
OPD NO 2,3 Kayachikitsa Department Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
OPD NO 2,3 Kayachikitsa Department Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
Solapur
MAHARASHTRA
413002
India |
| Phone |
7397884008 |
| Fax |
|
| Email |
pooja.mokashi@pg.sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vivek S Chandurkar |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
Solapur
MAHARASHTRA
413002
India |
| Phone |
9422788569 |
| Fax |
|
| Email |
vivek.chandurkar@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Manohar Mokashi |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya |
| Address |
OPD NO 2,3 Kayachikitsa Department Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
OPD NO 2,3 Kayachikitsa Department Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
Solapur
MAHARASHTRA
413002
India |
| Phone |
7397884008 |
| Fax |
|
| Email |
pooja.mokashi@pg.sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Manohar Mokashi |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur |
| Type of Sponsor |
Other [Gov Grant In Aid Ayurved 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 Pooja Manohar Mokashi |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
Solapur
MAHARASHTRA |
7397884008
pooja.mokashi@pg.sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Khadirashtaka Kwatha, Reference: Yogaratnakara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Nishadi Kwatha , Reference: Ashtanga Hrudaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects of diagnosed vicharchika.
2)Subjects of age group between 20-60 years irrespective of sex, religion, occupation and socio-economic status will be selected.
|
|
| ExclusionCriteria |
| Details |
1)Subjects of vicharchika with any secondary complications.
2)Subjects, who don’t agree to take medicine in kwatha form.
3)Subjects who are suffering from any other known case of systemic diseases i.e. Uncontrolled DM, Cancer etc.
4)Subjects having congenital anomaly related to immune system.
5)Pregnant, lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To evaluate the efficacy of Khadirashtaka Kwatha in the management of Vicharchika.
2)To evaluate the comparative efficacy of Khadirashtaka Kwatha and Nishadi Kwatha in the management of Vicharchika.
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)To analyze the process of samprapti vighatana of vicharchika. |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
15/05/2023 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Vicharchika makes worried the Subject due to its appearance,
intense itching, disturbing day to day routine life and its nature
susceptible to be chronic. Vicharchika
is one of the common skin disease having most prevalent among both in rural
and urban areas. The prevalence of atopic eczema in 56 countries had been
found to vary between 3% to 20.5%. The prevalence of Vicharchika in India is about 6.75%2. General medical
practices Offers treatment for the symptom of Vicharchika. However, it does not provide treatment for the root
of disease. Therefore, recurrence is very common. Ayurveda offers treatment
for the root of Vicharchika by
removing vitiated Doshas by shodhana chikitsa3 and
balancing the Dosha, Dhatu and Malas by shamana chikitsa. Ayurveda believes that All Doshas, Dhatus and Malas
are in balance4 is very essential for healthy well-being.
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|