| CTRI Number |
CTRI/2024/12/078651 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The study of treatment on Psoriasis by thermocauterization (agnikarma) using cows teeth and blood letting (siravedh) procedure. |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF AGNIKARMA WITH GODANTA AND SIRAVEDH IN THE MANAGEMENT OF KITIBHA KUSHTA WITH SPECIAL REFERENCE TO PSORIASIS IN AGE GROUP OF 18-70 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 Akash Anantrao Bhojane |
| Designation |
PG Scholar Shalyatantra department |
| Affiliation |
DMM Ayurved Mahavidyalaya Yavatmal |
| Address |
DMM Ayurved Mahavidyalaya Arni Road Shivaji nagar,Yavatmal
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.
Ayurved Rugnalaya Department of Shalaytantra Ground floor OPD
No.5 Yavatmal
MAHARASHTRA
445001
India
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9370797396 |
| Fax |
|
| Email |
mh28au0056@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxminivas Rajgopalji Soni |
| Designation |
Professor and HOD Shalyatantra department |
| Affiliation |
DMM Ayurved Mahavidyalaya Yavatmal |
| Address |
DMM Ayurved Mahavidyalaya Arni road Shivaji nagar, Yavatmal
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.
Ayurved Rugnalaya Department of Shalaytantra Ground floor OPD
No.5 Yavatmal
MAHARASHTRA
445001
India
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9422281424 |
| Fax |
|
| Email |
lrsoni10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash Anantrao Bhojane |
| Designation |
PG Scholar Shalyatantra department |
| Affiliation |
DMM Ayurved Mahavidyalaya Yavatmal |
| Address |
DMM Ayurved Mahavidyalaya Arni Road Shivaji nagar,Yavatmal
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.
Ayurved Rugnalaya Department of Shalaytantra Ground floor OPD
No.5 Yavatmal
MAHARASHTRA
445001
India
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9370797396 |
| Fax |
|
| Email |
mh28au0056@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Shivaji nagar, Aarni road, Yavatmal 445001 |
|
|
Primary Sponsor
|
| Name |
DMM Ayurved Mahavidyalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Department of Shalyatantra, Ground floor OPD No.05, Shivaji Nagar,Yavatmal, Aarni road Dist.Yavatmal 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 Akash Anantrao Bhojane |
L.K.Ayurved Rugnalaya,Yavatmal |
Department of Shalyatantra, Division 1, Room no 5,DMM Ayurved Mahavidyalaya,Shivaji nagar, Aarni road, Yavatmal 445001 Yavatmal MAHARASHTRA
Yavatmal
MAHARASHTRA |
9370797396
mh28au0056@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee,D.M.M Ayurved Mahavidyalaya,Yavatmal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta samhita Sutrasthan 12/04 , Procedure details: Method 1 : Agnikarma with Godanta :
(For Sthanik dosh nirharan) On 1St , 14th ,28th day
PURVAKARMA :
(Pre-procedure of agniKarma) :
Pre AgniKarma Diet :
The Agnikarma is deployed on the patients in
all the disease & during
All the seasons after giving sticky food.
PRADHANKARMA :
PradhanaKarma (Principal procedure of AgniKarma)
1)The patient kept in suitable position by keeping head in the East direction & held by expert assistants to avoid movement.
2)After this the surgeon should make the different shapes of Agnikarma viz.:- Valaya, Ardhchandra, Swastika, etc. as per need by heated godanta Shalaka.
3)During this period if patients feel discomfort then will keep them stable by courageous, consolations talks, give cold water for drink & sprink cold water.
4)Procedure of AgniKarma will be done till production of complete cauterisation.
PASCHATKARMA :
1)(Post AgniKarma Management) After proper cauterization,
honey & ghee applied.
2) Application of honey & ghee are to bring back normalcy in Rakta & Pitta which get vitiated by Agnikarma & to pacify the pain.)
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group above 18 years and below 70 years.
2) Patient having classical signs and symptoms
of kitibh kushta.
3) Patient willing for clinical trial. Irrespective of gender, occupation, Religion, economical Barrier.
4) Patient willing to participate.
5) Patient who will fulfil criteria with regular follow up. |
|
| ExclusionCriteria |
| Details |
1) Age group below 18 years and above 70 years.
2) Pregnant and lactating mother.
3) Infective origins like Scabies,Fungal infection,herpes zoster.
4) Immune compromised like HIV
5) Diabetic person
6) Patient having cardiac disease
7) Renal diseases. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The parameters will be noted down before and after treatment,The patient will be diagnosed based on symptoms of Kitibha kushta (Psoriasis) explained in Ayurvedic and Modern texts.
1) Kinakhara sparsha (Scaling)
2) Shyawam (Greyish Discolouration)
3) Parusha (Dryness)
4) Sravi(Discharge),
5) Vritta (Oval to round Lesions)
6) Ghana(Elevation)
7) Ugrakandu (Severe pruritis) |
Method 1 : Agnikarma with Godanta will be done On
1St,14th,28th day
Method 2 : Siravedh On
7th,21st,35th day
Follow up on 42th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All parameters will be assessed before and after treatment. 1) No improvement – 0 % relief in signs and symptoms. 2) Poor improvement – 0%-25% relief in sign and symptoms 3) Mild improvement – 26% to 50% improvement in signs and symptoms 4) Moderate improvement – 51% to 75 % improvement in signs and symptoms 5) Marked improvement – 76% to 100% improvement in signs and symptoms. |
Method 1 : Agnikarma with Godanta will be done On
1St , 14th ,28th day Method 2 : Siravedh On
7th , 21st , 35th day
Follow up on 42th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/01/2025 |
| 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 is “the science of lifeâ€. Ayurveda is not only curative but also preventive science of life. Ayurveda has 8 branches (Astang Ayurveda). Shalyatantra is one of the important branch of Ashtanga Ayurveda in which surgical and para-surgical techniques are described for various diseases. In healthcare sector tremendous research has been conducted to treat different types of skin disease. In Ayurveda, The word Kushta is broad term, which covers almost all skin disorders. “कषà¥à¤£à¤¾à¤¤à¥€ इतत कषà¥à¤ म†(मा.ति./कषà¥à¤ /टीका 1) According to Ashtang hrudaya,in kushta due to vitiated dosha the part of skin becomes affected and changes its normal colour called kushtha. Ayurveda has given importance to skin disease and reference of kushtha can be found since vedic period. This Kitibha Kushtha can be co-related to psoriasis in clinical features has been classified and explained under kshudra kushta. Ayurvedic classics have considered each type of Kustha to be a Tridosaja manifestation. Their Doshik identity can be established on the basis of dominance of Dosha in the Samprapti. Thus Kitibhakustha is Vata-Kaphaja The signs and symptoms of psoriasis resemble with those of vatakapha dushti. Among vatakaphaj kushtha types, kitibh kushtha is most similar in presentation. So by using the law of “Vyapadeshastu bhuyasaâ€, Psoriasis can be correlated with kitibh kushtha Psoriasis is one amongst these notorious auto-immune disorders having deep psychological and social impacts. It is a chronic inflammatory disease with skin manifestations, aggravated by or can recur by number of triggering factors such as psychological,dietary, environmental changes, medications, etc. The prevalence of Psoriasis is raising an alarming picture, as presently about 120-180 million of global population suffer from Psoriasis. Agnikarma is a unique procedure where heat is conducted to the affected tissue with help of variety of materials. A fire (cautery) is better than Alkali as far as its healing property is concerned. A disease burnt with fire, is cured for good and knows no recrudescence; It enjoys the label of ‘Apunarbhav Chikitsa’, i.e. diseases cured by this process are uprooted radically! |