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CTRI Number  CTRI/2022/06/042961 [Registered on: 01/06/2022] Trial Registered Prospectively
Last Modified On: 01/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative clinical trial to study the effect of Darvyadi Niruhabasti and Panchatikta Panchaprasrutik Basti in the management of Kitibha Kushtha(psoriasis) 
Scientific Title of Study   Assessment of Darvyadi Niruhabasti & Panchatikta Panchaprasrutik Basti in the management of Kitibha Kushtha w.s.r. to Psoriasis - A comparative clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghavi Jitendrakumar Vaghamshi 
Designation  PG Scholar 
Affiliation  Parul Ayurved Hospital 
Address  Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9904709494  
Fax  02668-260201  
Email  meghavi.vaghamshi.1010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Patil 
Designation  Associate professer 
Affiliation  Parul Ayurved Hospital 
Address  Room No - 303, Department of Panchakarma, Parul Institute of Ayurveda, Parul University, Limda, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9039764509  
Fax  02668-260201  
Email  dr.dineshpatil3@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dinesh Patil 
Designation  Associate professer 
Affiliation  Parul Ayurved Hospital 
Address  Room No - 303, Department of Panchakarma, Parul Institute of Ayurveda, Parul University, Limda, Vadodara, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9039764509  
Fax  02668-260201  
Email  dr.dineshpatil3@gmail.com  
 
Source of Monetary or Material Support  
Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat, Pin no - 391760 
 
Primary Sponsor  
Name  Parul Ayurved Hospital 
Address  Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat, Pin no - 391760 
Type of Sponsor  Research institution and hospital 
 
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 
Meghavi Jitendrakumar Vaghamshi  Parul Ayurved Hospital  Panchakarma - OPD no 105 and IPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara, Gujarat, Pin no - 391760
Vadodara
GUJARAT 		 9904709494
02668-260201
meghavi.vaghamshi.1010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L40||Psoriasis. Ayurveda Condition: KITIBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka samhita, Siddhi sthana, Adhyaya 1, Sloka no. 48, Procedure details: Darvyadi Niruhabasti with Madanaditaila Anuvasanabasti in Yogabasti krama for 8 days)
(1) Medicine Name: Darvyadi Niruhabasti, Reference: Charaka samhita, Chikitsa sthana, Adhyaya 7, Sloka no. 46, Route: Rectal, Dosage Form: Not Applicable, Dose: 550(ml), Frequency: od, Duration: 3 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka samhita, Siddhi sthana, Adhyaya 1, Sloka no. 48, Procedure details: Panchatikta Panchaprasrutikbasti with Madanaditaila Anuvasanabasti in Yogabasti krama for 8 days)
(1) Medicine Name: Panchatikta Panchaprasrutikbasti, Reference: Charaka samhita, Siddhi sthana, Adhyaya 8, Sloka no. 8, Route: Rectal, Dosage Form: Not Applicable, Dose: 550(ml), Frequency: od, Duration: 3 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients presenting with clinical signs and symptoms of Kitibha Kushtha.
2. Kitibha Kushtha patients between the age group of 18 to 70 years.
3. Patients of either gender irrespective of caste and religion. 
 
ExclusionCriteria 
Details  1. Patients having other systemic disorders - known case of Hypertension, Carcinoma, Tuberculosis, Infectious diseases and other life threatening disorders.
2. Patients contraindicated for Shodhana such as Pregnant & lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Helps in reduction of signs and symptoms of psoriasis and recurrence of the disease will be controlled.  8 days of treatment
After 15 days of treatment follow up 
 
Secondary Outcome  
Outcome  TimePoints 
There will be increased quality of life in psoriasis patients and complications of the disease will be reduced.  25 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 2/ Phase 3 
Date of First Enrollment (India)   01/06/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [meghavi.vaghamshi.1010@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Psoriasis is one of the most common dermatological diseases affecting 2% of the World’s population. In India, the prevalence of Psoriasis varies from 0.44% to 2.8%. To date, no proper curative measures are found to treat psoriasis in modern science, so it is necessary to find a safe and effective measure for Psoriasis. Psoriasis has maximum resemblance with the Kitibha kushtha mentioned as a type of Kushtha in Ayurvedic classics so can be treated as per Kushtha chikitsa. As per Ayurveda’s unique treatment, Basti karma here is an attempt to study the efficacy of  Darvyadi Niruhabasti and Panchatikta Panchaprasrutik Basti with Madanadi taila Anuvasana Basti in the management of Kitibha Kushtha (Psoriasis).
RESEARCH QUESTION: 
Whether the Darvyadi Niruhabasti & Panchatikta Panchaprasrutik Basti with Madanaditaila Anuvasanabasti are effective in the Yogabasti krama in the management of Kitibha kushtha w.s.r. to psoriasis?
AIM: 
Comparison of the efficacy of Darvyadi Niruhabasti & Panchatikta Panchaprasrutik Basti along with Madanaditaila Anuvasanabasti in the management of Kitibha kushtha. 
OBJECTIVES:
  • To determine the effects of Darvyadi Niruhabasti and Madanaditaila Anuvasanabasti in the management of Kitibha kushtha. 
  • To determine the effects of Panchatikta Panchaprasrutik Basti and Madanaditaila Anuvasanabasti in the management of Kitibha kushtha.
  • To compare the efficacy of Darvyadi Niruhabasti & Panchatikta Panchaprasrutik Basti along with Madanaditaila Anuvasanabasti in the management of Kitibha kushtha. 
  • To evaluate the role of Basti treatment in the management of Kitibha kushtha.
MATERIALS AND METHODS:
  • Duration of Study: 18 months 
  • Study design: Randomized comparative clinical trial
  • Purpose of the study will be explained and written informed consent will be taken from every patient.
  • SOURCES OF DATA:
  1. LITERARY SOURCE: All classical, modern literature and contemporary texts including the journals and websites about the disease, drugs and procedures will be reviewed and documented for the study.
  2. PHARMACEUTICAL SOURCE: Madanaditaila for Anuvasanabasti will be prepared in the GMP certified Pharmacy of Parul Institute of Ayurveda. Niruhabasti will be prepared at Parul Ayurveda Hospital as per proper SOPs. 
  3. CLINICAL SOURCE: Diagnosed cases of Kitibha kushtha, will be selected from OPD and IPD of Parul Ayurveda Hospital, Limda, Vadodara.
TREATMENT GROUPS: 
Group A (Trial group) – 20 patients will be administered Darvyadi Niruhabasti and Madanaditaila Anuvasanabasti. 
Group B (Control group) – 20 patients will be administered Panchatikta Panchaprasrutik Basti and Madanaditaila Anuvasanabasti.
SUBJECTIVE CRITERIA – 
  • Shyavavarna 
  • Kinkhara sparsha 
  • Parushatva 
  • Kandu 
  • Scaling
OBJECTIVE CRITERIA – 
  • Auspitz sign 
  • Candle Grease test
  • PASI Score
INTERVENTION:
  • Yoga Basti: 8 days
 1st day 2nd day 3rd day4th day  5th day6th day  7th day8th day 
 AB NBAB NB AB NB AB AB 
   
Here, AB - Anuvasana Basti, NB - Niruha Basti
  • Basti Quantity: 1. Niruha Basti - 550 ml 2. Anuvasana Basti - 70 ml
  • Follow up - 15 days after treatment of 8 days 
The effect of the Basti (Panchakarma therapy) will be assessed based on the following criteria – 
  • Samyak Basti Lakshanas 
  • The retention time of Basti
  • Number of purisha vega
  • Possible complications after administration of Basti 
  • Vital data of patients 


 
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