| CTRI Number |
CTRI/2025/02/080257 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to test and compare the effectiveness of Vamana karma done using Madanaphala Pippali Choorna and Indrayava Choorna randomly divided into two groups of 15 patients diagnosed with Kitibha kushta(Psoriasis). |
|
Scientific Title of Study
|
A Randomized Single blind Comparative Clinical study to Evaluate the Efficacy of Vamana karma with Madanaphala Pippali Choorna and Indrayava Choorna in the Management of Kitibha Kushta W.S.R to 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 Ananya Bhat |
| Designation |
Post Graduate Student |
| Affiliation |
KVG Ayurveda Medical College and Hospital |
| Address |
OPD Room No.1
Department Of Panchakarma
KVG Ayurveda Medical College
Ambate adka Kurunjibag Sullia
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
8105864970 |
| Fax |
|
| Email |
dr.ananya22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lakshmeesha K S |
| Designation |
Professor |
| Affiliation |
KVG Ayurveda Medical College and Hospital |
| Address |
OPD Room No.1
Department Of Panchakarma
KVG Ayurveda Medical College
Ambate adka Kurunjibag Sullia
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
8618237712 |
| Fax |
|
| Email |
dr.lakshmeesha1987@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Lakshmeesha K S |
| Designation |
Professor |
| Affiliation |
KVG Ayurveda Medical College and Hospital |
| Address |
OPD Room No.1
Department Of Panchakarma
KVG Ayurveda Medical College
Ambate adka Kurunjibag Sullia
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
8618237712 |
| Fax |
|
| Email |
dr.lakshmeesha1987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ananya Bhat
KVG Ayurveda Medical College and Hospital Ambate adka kurunjibag sullia 574327 |
|
|
Primary Sponsor
|
| Name |
Dr Ananya Bhat |
| Address |
KVG Ayurveda Medical College
Ambate Adka kurunjibag Sullia 574327 |
| 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 |
| Dr Ananya Bhat |
KVG Ayurveda Medical College and Hospital |
OPD Room No.1
Department Of Panchakarma
Ambate adka KurunjibagSullia Dakshina Kannada KARNATAKA |
8105864970
dr.ananya22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Ayurveda Medical College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L408||Other psoriasis. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Madhanaphala pippali choorna , Reference: charaka samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: saindhava and madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Indrayava choorna , Reference: charaka samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: saindava and madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Classical signs and symptoms of kitibha kushta including the following
Shyava varna or Blackish discoloration
Khinakhara sparsha or Dry and Coarse to touch wound like appearance
Parushatva or Roughness
Srava or Exudative powdery discharge
Kandu or itching
Patients of Psoriasis presenting with skin lesions associated with the following
Itching
Discharge
Erythema
Induration
Scaling
Subjects who meet the following criteria will be included in the study
Patients of any gender fulfilling the Diagnostic criteria
Patients aged between eighteen years to sixty years of age
|
|
| ExclusionCriteria |
| Details |
Patients who are not eligible for vamana karma assessed based on indications and contraindications of vamana karma mentioned in classical texts of ayurveda
Patients aged below eighteen years and above sixty years of age
Patients associated with chronic systemic illnesses like psoriatic arthritis carcinoma diabetes mellitus hypertension cardiac abnormalities and other life threatening conditions
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Test the therapeutic Efficacy of Vamana karma
To compare the efficacy of the two drugs used for vamana karma namely Madanaphala pippali choorna and Indrayava choorna |
After deepana pachana (day3 to day5), after snehapana (day 6 to day 12), on the day of vamana (day 14) and after samsarjana krama (day 16 to day18) and after 7 days post samsarjana krama (day25)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
resolution of signs & symptoms of kitibha kushta (psoriasis)
Improvement in the quality of life |
After deepana pachana (day3 to day5), after snehapana (day 6 to day 12), on the day of vamana (day 14) & after samsarjana krama (day 16 to day18) & after 7 days post samsarjana krama (day25)
before & after treatment assesment gradings
PASI score (psoriasis area & severity index)
DLQI score (Dermatology life quality index)
PGA score (Physician Global assessment)
Auzpitz sign
Candle grease test
Discharge
Discoloration |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
15/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/04/2026 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Panchakarma, a branch unique to Ayurveda, mainly attracts the
attention of people for its multi factorial action of curative, promotive as
well as preventive benefits. As global acceptance and awareness has
tremendously increased in the recent years, it is the need of the hour to work
on individual Karma, with
different formulations for different diseases, in a scientific manner.
Kitibha Kushta, according to
Ayurveda, is a type of skin disorder characterized by raised, rough patches or
papules on the skin. It is classified under Kshudra Kushta, which encompasses
various minor skin conditions. Ayurvedic texts describe Kitibha Kushta as
predominantly caused by aggravated Kapha and Vata doshas, along with dietary
and lifestyle factors. It can be corelated to psoriasis in contemporary
science.
Psoriasis is a
chronic, noncommunicable, painful, disfiguring and disabling disease and has a
significant negative impact on patients’ quality of life. Skin lesions are
localized or generalized, mostly symmetrical, sharply demarcated, reddish black
papules and plaques, and usually covered with white or silver scales. Lesions
also cause itching and stinging type of pain.
The reported
prevalence of psoriasis worldwide ranges between 0.09% and 11.4%, making
psoriasis a serious global problem. In
India alone, the incidence of psoriasis is about 1.4% to 2% of the total
population.
There are three
major methods of management which include topical therapy, phototherapy and
systemic therapy. The need for treatment is usually lifelong and is aimed at
remission. Shodhana, a multi-dimensional modality of intervention exclusively
mentioned in Ayurveda, mainly focuses on elimination of the disease-causing
factors from the source, thereby reducing symptoms and re-occurrence of the
disease. Vamana karma is one such Shodhana therapy, wherein, medically induced
vomiting, in a controlled environment results in elimination of excess mucous
and other kapha-related toxins from the body thereby bestowing the person with
comprehensive detoxification and rejuvenation.
Therefore, in the present
study Vamana Karma is
opted as the treatment methodology in the management of kitibha kushta (psoriasis).
In the classical texts, many
different formulations are described for Vamana Karma but only a few are in
practice. Shodhita Madanaphala Pippali (Randia dumetorum Linn) [2] (Madanaphala Beeja) is
commonly used since it has Kashaya tikta rasa, kaphahara and lekhana properties
and less complications during vamana karma. Indrayava (Kutaja Beeja) is also
mentioned as a potent vamaka Dravya with krimigna, kushtagna, raktha shodhaka,
shoolaprashamana and vrana ropana properties.
Hence, this study is aimed to
evaluate the efficacy of Vamana karma using Madanaphala Pippali choorna and
Indrayava choorna in cases of kitibha kushta (psoriasis), titled “A RANDOMIZED
SINGLE BLIND COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VAMANA
KARMA WITH MADANAPHALA PIPPALI CHOORNA AND INDRAYAVA CHOORNA IN THE MANAGEMENT
OF KITIBHA KUSHTA W.S.R.TO PSORIASIS.” |