| CTRI Number |
CTRI/2024/11/076632 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effect of Virechan karma with Haritakyadi Modak in treating Vicharchika with special reference to Eczema |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Virechan karma with Haritakyadi Modak in the management of 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 |
Soumya Suresh Chinta |
| Designation |
Post graduate resident |
| Affiliation |
APMs Ayurved mahavidyalaya Sion Mumbai |
| Address |
Department of Panchkarma, second floor,
APMs Ayurved mahavidyalaya,
near sion railway station
Sion
Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9867329090 |
| Fax |
|
| Email |
soumyachinta56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Govind More |
| Designation |
Associate Professor |
| Affiliation |
APMs Ayurved mahavidyalaya Sion Mumbai |
| Address |
Departemnt of Panchkarma, second floor,
APMs Ayurved mahavidyalaya,
near sion railway station
Sion
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967520554 |
| Fax |
|
| Email |
rmrushi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Govind More |
| Designation |
Associate Professor |
| Affiliation |
APMs Ayurved mahavidyalaya Sion Mumbai |
| Address |
Departemnt of Panchkarma, second floor,
APMs Ayurved mahavidyalaya,
near sion railway station
Sion
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967520554 |
| Fax |
|
| Email |
rmrushi@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurved Mahavidyalaya Sion, near sion railway station, sion east, Mumbai 400022
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Soumya Suresh Chinta |
| Address |
APMs Ayurved mahavidyalaya Sion
near sion railway station
Mumbai 400022 |
| 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 |
| Soumya Suresh Chinta |
Seth R V Ayurvedic hospital, Sion |
Departemnt of Panchkarma OPD no. 1,near sion railway station, Mumbai
Mumbai
MAHARASHTRA |
9867329090
soumyachinta56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved mahavidyalaya IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L30||Other and unspecified dermatitis. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: charak kalpasthana chapter 1, shlok number 4, Procedure details: Poorva Karma – The participant will be given rukshan drug as per necessity. For internal Snehan, Go ghrut will be provided with
instruction regarding dose according to the koshtha and status of agni of the participant after doing rukshan. External snehan and
swedan will be done for 2 days.
Pradhan Karma – Virechan drug will be given in the early morning and the number of vega and symptoms will be assessed for evaluating the type of shuddhi.
Pashchat karma – Sansarjan Kram will be advised for 3, 5 or 7 days as per the type of shuddhi happened on the day of virechan
)
(1) Medicine Name: Haritakyadi modak, Reference: Vangsen samhita virechana adhyay shlok number 24,25, Route: Oral, Dosage Form: Modaka, Dose: 24(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of any gender, between age 18-55 years of age,
2)Patiens having symptoms of vicharchika like kandu, strava, pidika, vaivarnya and rukshata.
3)Patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1)Patients diagnosed with carcinoma, tuberculosis, HIV positive or any other life-threatening condition.
2)Patients having any ano-rectal diseases like fistula, fissure-in-ano, hemmorhoids.
3)Pregnant and lactating women.
4)Patient with other debilitating disease like TB/SLE
5)Patients not fit for Virechan karma. (Virechan ayogya patients) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of drug on morphological features of the lesion: Using butter paper external margins of eczematic patch will be marked before and after treatment. Using maximum longitudinal length and vertical length area will be calculated before and after. |
15 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of drug on vaivarnya (de-pigmentation) of the lesion.
Effect of drug on kandu (itching) of the lesion.
Effect of drug on srava (discharge) of the lesion.
Effect of drug on pidika (eruption) of the lesion.
|
15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="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
|
Vicharchika (Eczema) is one of the Kshudra Kushthas (chronic skin disorder) and is included under Rakta Pradoshaja Vikaras (disorder due to blood vitiation). Being a type of Kushtha, recurrences and chronic course is common for this disease. Vicharchika can be correlated with eczema which is characterized by persistent or recurring skin rashes, running a chronic course, and has a tendency of exacerbations. Hence, while selecting regimen for its total eradication, in addition to its own treatment, it is necessary to take care of its recurrences also. The main line of treatment described for Kushtha is repeated Shodhana (bio-purification), so that the disease can be eradicated from the root. Of Panchakarma, Virechana (systemic purification by giving purgative drug) is better for the skin diseases where Pitta and Rakta are mainly involved. In modern science, treatment of Eczema is giving oral medications like NSAIDS, corticosteroids and anti-histamines. Topically, corticosteroids are given to reduce itchiness, swelling and redness. In Ayurveda, the main line of treatment of Vicharchika vyadhi is repeated shodhan (bio-purification), since Virechan karma is advised for all skin diseases, I’ve taken Virechan with Haritakyadi modak in Vicharchika (Eczema) for my study. The participant will be given rukshan drug as per necessity. For internal Snehan, Go ghrut will be provided with instruction regarding dose according to the koshtha and status of agni of the participant after doing rukshan. External snehan and swedan will be done for 2 days. Virechan drug will be given in the early morning and the number of vega and symptoms will be assessed for evaluating the type of shuddhi. Sansarjan Kram will be advised for 3, 5 or 7 days as per the type of shuddhi happened on the day of virechan. The changes in the symptoms will be evaluated on daily basis and data would be analyzed on the basis of data collected by applying appropriate statistical tools. |