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CTRI Number  CTRI/2025/11/097178 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 08/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparitive clinical study on efficacy of bhallatakadya churna and somraji tail with psora capsule and psora oil in the management of psoriasis 
Scientific Title of Study   Comparitive clinical study on efficacy of bhallatakadya churna and somraji tail with psora capsule and psora oil in the management of ekkushtha with reference 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  Shilpi Gangwani 
Designation  PG Scholar 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College 
Address  Department of Kayachikitsa Shri NPA Government Ayurveda College Raipur Chhattisgarh India 492010

Raipur
CHHATTISGARH
492010
India 
Phone  8319666874  
Fax    
Email  shilpigangwani07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Aruna Ojha 
Designation  Professor and HOD of Kayachikitsa Department 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College 
Address  Department of Kayachikitsa Shri NPA Government Ayurveda College Raipur Chhattisgarh India 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Manoj Kumar Dash 
Designation  Associate Professor of Department of Rasa Shastra and Bhaishajya Kalpana 
Affiliation  Government Ayurved College Bilaspur 
Address  Department of Rasa Shastra and Bhaishajya Kalpana Government Ayurved College Bilaspur Chhattisgarh India 495001

Bilaspur
CHHATTISGARH
495001
India 
Phone  8817708049  
Fax    
Email  drmanojkumardash@gmail.com  
 
Source of Monetary or Material Support  
Shri NPA Govt. Ayurved College Raipur Chhattisgarh,492010  
 
Primary Sponsor  
Name  Department of Kayachikitsa Shri NPA Govt Ayurved College Raipur CG 
Address  OPD No. 02 & 20 ,Department of Kayachikitsa Shri NPA Government Ayurved College Raipur Chhattisgarh 
Type of Sponsor  Other [Government Ayurved College Raipur Chhattisgarh] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shilpi Gangwani  Shri Khudadad Dunga ji Ayurved College and Hospital Raipur Chhattisgarh  OPD No. 2 and 20 and IPD in the Department of kayachikitsa Shri NPA Government Ayurveda College Raipur Chhattisgarh India 492010 GE Road opposite central library raipur , 492010 C.G.
Raipur
CHHATTISGARH 
8319666874
0
shilpigangwani07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee govt. ayurved college raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Bhallatakadya Churna , Reference: Gad Nigraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Somraji tail, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmDrugOther than Classical(1) Medicine Name: Psora Capsule, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
4Comparator ArmDrugOther than Classical(1) Medicine Name: Psora Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients between the age group of 30 and 60 years will be taken.
2.Gender - male and female both.
3. Patients having symptoms mentioned in WHO grading scale will be taken.
4. Patients who are willing and ready to follow treatment protocol, have signed written informed consent to participate consent to participate in the study.  
 
ExclusionCriteria 
Details  1. Uncontrolled diabetes and hypertension.
2. Chronic liver, heart, kidney disorder.
3. Carcinoma.
4. Tuberculosis.
5. Pregnant and lactating women.
6. Patients who are under steroid or methotrexate medication and are willing to continue this treatment.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To prevent the recurrence of ekkushtha.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
To manage the stress level of patient as it is the major factor in recurrence.  60 days 
 
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   Phase 1 
Date of First Enrollment (India)   01/03/2026 
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="0"
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  

INTRODUCTION

 

Skin is the largest organ in the body and barrier between body’s internal as well as external environment. In ayurveda skin is one among five gyanendriya’s responsible for ‘sparsh gyan’ and skin disease are collectively considered under a common term ‘kushtha’ where ekkushtha is one under it which finds similarity with psoriasis.

Psoriasis is a chronic systemic autoimmune skin disorder characterized by well defined erythematosus plaques covered by silvery flaky scales mainly affecting skin and joints. Its prevalence in  World is 2-3% of total population and in India it is about 0.44-2.8%. Males are being affected by psoriasis more than female.

The exact etiology of psoriasis is still not established but certain diets, environmental factors ,genetic factors and immunological factors are considered the cause of it. In ayurveda it is mentioned that aharaj nidan like taking excessive amount of newly formed rice, heavily digestible food , citrus fruits, curd, fish, unrefined sesame oil and viharaj nidan like sleeping at day time, supressing the natural urges of body, excessive exposure to sunrays, excessive worry, grief are the causative factors. Other factors such as seasonal changes, alcohol, hypocalcemia and some infections can also trigger psoriasis.

The common sites of occurrence of psoriasis are scalp, elbow, knee, earlobes and sole which are also considered as the location of kapha and vata. The derangement of seven factors involving tridoshas (vata, pitta, kapha) along with twak (skin), rakta (blood tissues),  mamsa  (muscle tissues) and lasika (blood plasma) are the basis of vitiation of srotas . These vitiated factors enter into gambhir dhatus(deeper body tissue element) and srotas (body channels) producing scaly lesion and other symptoms.

 BASIS OF MEDICINE SELECTION

 

1.     Bhallatakadya churna is classic ayurvedic formulation mentioned in kushtha chapter of shloka no. 302,303,304 of gad nigraha having contents which collectively works as rakta shodhak and prasadak , has immune modulation, and anti stress properties along with vatakapha shamak effect which would help in breaking the pathology of ekkushtha.

2.     Bakuchi and bhallatak present in the drug has kushthaghna properties that directly act on skin disorders especially chronic ones.

3.     Bakuchi is present in bhallatakadya churna as well as somraji tail which has properties like raktashodhak, (blood purifying effect), lekhan (helps in removing dead skin), and varnya(improves complexion of skin)

4.     Bramhi and Shankhpushpi has anti stress properties which will reduce the stress of the patient.

5.     Haldi and Daruhaldi present in the Somraji Tail has  anti inflammatory ,kandughna, and rakta shodhak properties. 

 

NEED OF STUDY

 

1.     To fill the gap in current state of ayurveda research so as to identify trigger factors, relapsing and recurring condition of psoriasis.

2.     The chronic nature, recurring pattern and visibility of psoriasis produces a huge adverse impact on the psychological and social aspect of patient life.

3.     Psychological disability affects the daily routine as well as social interaction.

4.     In present era, skin disorders are commonly found in day to day practice and according to roxburgh’s common skin disease book approx 10-15% of the patients suffering from psoriasis do not respond to available therapies. Therefore a complete successful treatment method along with dietary changes to reduce its reccurence is needed which would be highly effective.

5.     Psoriasis affects quality of life , ayurvedic studies can help develop community level guidelines for prevention, awareness, and early intertvention.

6.     Psoriasis involves both skin and systemic issues like inflammation,stress,immunity and ayurveda provides a mind body approach through diet (ahara), lifestyle (vihara) and mental wellness practices (satvavjay chikitsa)

 

BASIS OF MEDICINE SELECTION

 

1.     Bhallatakadya churna is classic ayurvedic formulation mentioned in kushtha chapter of shloka no. 302,303,304 of gad nigraha having contents which collectively works as rakta shodhak and prasadak , has immune modulation, and anti stress properties along with vatakapha shamak effect which would help in breaking the pathology of ekkushtha.

2.     Bakuchi and bhallatak present in the drug has kushthaghna properties that directly act on skin disorders especially chronic ones.

3.     Bakuchi is present in bhallatakadya churna as well as somraji tail which has properties like raktashodhak, (blood purifying effect), lekhan (helps in removing dead skin), and varnya(improves complexion of skin)

4.     Bramhi and Shankhpushpi has anti stress properties which will reduce the stress of the patient.

5.     Haldi and Daruhaldi present in the Somraji Tail has  anti inflammatory ,kandughna, and rakta shodhak properties. 

 

NEED OF STUDY

 

1.     To fill the gap in current state of ayurveda research so as to identify trigger factors, relapsing and recurring condition of psoriasis.

2.     The chronic nature, recurring pattern and visibility of psoriasis produces a huge adverse impact on the psychological and social aspect of patient life.

3.     Psychological disability affects the daily routine as well as social interaction.

4.     In present era, skin disorders are commonly found in day to day practice and according to roxburgh’s common skin disease book approx 10-15% of the patients suffering from psoriasis do not respond to available therapies. Therefore a complete successful treatment method along with dietary changes to reduce its reccurence is needed which would be highly effective.

5.     Psoriasis affects quality of life , ayurvedic studies can help develop community level guidelines for prevention, awareness, and early intertvention.

6.     Psoriasis involves both skin and systemic issues like inflammation,stress,immunity and ayurveda provides a mind body approach through diet (ahara), lifestyle (vihara) and mental wellness practices (satvavjay chikitsa)

In this study two groups are taken , having sample size of 40 and each group has 20 participants . In 1st group Bhallatakadya Churna and Somraji Tail will be given and in 2nd group Psora Capsule and Psora Oil (from Ayulabs pharmaceuticals )will be given. 

ANTICIPATED OUTCOME-

1.     Bhallatakadya Churna and Somraji tail will prevent the recurrence of ekkustha.

2.     Bhallatakadya Churna will manage the stress level of the patient very well as it has drugs like brahmi, shankhpushpi having anti stress properties in its composition.

 

 

 
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