| CTRI Number |
CTRI/2025/01/079511 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Therapeutic Clinical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Khadirashtaka kwatha and Brihat manjishtadi kwatha in the management of Ekakushta(Plaque psoriasis) |
|
Scientific Title of Study
|
Randomized Comparative study to evaluate the efficacy of Khadirashtak kwatha and Brihat manjishtadi kwath in Ekakushta w s r Plaque psoriasis |
| 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 Megha K |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar |
| Address |
First floor Room no 108
Department of Kayachikitsa Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar Southwest Delhi India
South West DELHI 110073 India |
| Phone |
9400145418 |
| Fax |
|
| Email |
meghababu48@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Atal Bihari Trivedi |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Southwest DELHI 110073 India
South West DELHI 110073 India |
| Phone |
9958046550 |
| Fax |
|
| Email |
abdratal8@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Atal Bihari Trivedi |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Southwest DELHI 110073 India
South West DELHI 110073 India |
| Phone |
9958046550 |
| Fax |
|
| Email |
abdratal8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar Southwest Delhi India
110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar,Delhi-110073 |
| Type of Sponsor |
Government 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 Megha K |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
PG Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar South West Delhi South West DELHI |
9400145418
meghababu48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chaudhary Brahm Prakash Ayurved Charak Sansthan Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadirashtaka Kwatha, Reference: Yogaratnakara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnambu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brihat Manjishtadi Kwatha, Reference: Sarngdhara Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -pippali guggulu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient showing sign and symptoms of Ekakushtha as mentioned in Charak Samhita
2 Patient within the age group of 21-60 years
3 Disease duration more than 1year and less than 5years
4 Patients not taking corticosteroids since last one month
|
|
| ExclusionCriteria |
| Details |
1 Patients of Diabetes mellitus, Thyroid disorder, tuberculosis, carcinoma, other life-threatening and complicated disease and major systemic illnesses
2 Severe condition of Psoriasis like Psoriatic arthritis
3 Disease duration less than 1year and more than 5years
4 Patients on treatment with any conventional oral medicines for last one month
5 Pregnant & lactating mother
6 Age below 21 and above 60 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptom severity of Ekakushtha |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Psoriasis Area and Severity Index (PASI)Score
Improvement in values of CBC, ESR
|
30days |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| Date of Study Completion (India) |
24/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Ekakushta is one among eleven varieties of kshudrakusthas described in Ayurvedic classics. lt is characterized by Aswedanam (Anhydrotic/hypohydratic lesions), Mahavastu (covering of large surface area), Matsyashakalopamam(scaly lesions), Twacha which bears a greater resemblance with the symptoms of plaque psoriasis. According to Charaka, the type of Kushtha which does not sweat, extensively spreads and resemble in the form of fish scale is known as Ekakustha. Ekakustha is Raktapradosaj vikara. The Doshadhikya of this disease is Vata-Kaphapradhan It is described as one of the chronic disorders (Dirgha-Roga) by Acharya Charaka.According to Sushruta it is the type of Kshudrakushta in which the entire body become blackished. Psoriasis is a common papulo-squamous disorder affecting 2% of the population and is characterized by well demarcated, red, scaly plaques. The skin becomes inflamed and hyper proliferates at about ten times the normal rate. It affects males and females equally and can involve all races. Psoriasis is T-lymphocyte-driven disorder that is a response to unidentified antigen. Un-identified triggers or infective agents like bacteria, HIV, drugs induce antigens which are presented to T lymphocytes by Langerhans cells of skin leading to a T cell activation activated cytokines that promote dermal inflammation and result into hyper-proliferation of epidermis. Different patterns of psoriasis are recognized and can occur together, Certain drugs can make psoriasis worse; notably lithium, antimalarials and beta-blockers. Chronic plaque psoriasis is the most common type of psoriasis. It is characterized by pink-red, well demarcated plaques, with a silver scale seen especially on extensor surfaces of the knees and elbows. Psoriasis is considered as a type of Kushta and may be correlated as Ekakushtha due to resemblance of signs and symptoms. In which both genetic and environmental influences have a critical role. The most characteristic lesions consist of red, scaly, sharply demarcated, and present particularly over extensor surfaces and scalp. There are many treatments available but because of its chronic recurrent nature psoriasis is a challenge to treat "Kustha is described as one of the most chronic disorders (Dirgha-Roga) by Acharya Charaka GroupA-Khadirashtaka kwatha will be administered at the dosage of 40ml twice daily with lukewarm water one hour before meals. Group B-Brihat Manjishtadi Kwatha will be administered at the dosage of 40ml twice daily with pippali and guggulu one hour before meals. The study design is single-centred,open label,randomized,comparative,interventional study |