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CTRI Number  CTRI/2025/03/083603 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Measurement of the levels of Mercury and Arsenic in blood and urine of psoriasis patient prescribed with Arogyavardhini vati and Rasamanikya  
Scientific Title of Study   An Observational study to assess the levels of Mercury and Arsenic in the patients of Kitibhakushtha receiving Arogyavardhini vati and Rasamanikya 
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 Jha Mohan Yogendra 
Designation  PhD Scholar 
Affiliation  All India Institue of Ayurveda 
Address  All India Institue of Ayurveda (An Autonomous Organization under the Ministry of AYUSH, Govt. India) Gautam Puri, Sarita Vihar, Mathura Road, New Delhi-110076

South
DELHI
110076
India 
Phone  7208490355  
Fax    
Email  jhamohan1802@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Yadav 
Designation  Associate professor, RSBK Department, AIIA New Delhi  
Affiliation  All India Institue of Ayurveda  
Address  All India Institue of Ayurveda (An Autonomous Organization under the Ministry of AYUSH, Govt. India) Gautam Puri, Sarita Vihar, Mathura Road, New Delhi-110076

South
DELHI
110076
India 
Phone  7208490355  
Fax    
Email  drpramod88@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Jha Mohan Yogendra 
Designation  PhD Scholar 
Affiliation  All India Institue of Ayurveda 
Address  All India Institue of Ayurveda (An Autonomous Organization under the Ministry of AYUSH, Govt. India) Gautam Puri, Sarita Vihar, Mathura Road, New Delhi-110076

South
DELHI
110076
India 
Phone  7208490355  
Fax    
Email  jhamohan1802@gmail.com  
 
Source of Monetary or Material Support  
All India Institue of Ayurveda (An Autonomous Organization under the Ministry of AYUSH, Govt. India) Gautam Puri, Sarita Vihar, Mathura Road, New Delhi-110076 
 
Primary Sponsor  
Name  AIIA Director  
Address  All India Institute of Ayurveda Gautam Puri, Sarita Vihar, Mathura Road, New Delhi-110076 
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 
Dr Jha Mohan Yogendra  All India Institue of Ayurveda  All India Institue of Ayurveda (An Autonomous Organization under the Ministry of AYUSH, Govt. India) Gautam Puri, Sarita Vihar, Mathura Road, New Delhi-110076
New Delhi
DELHI 		 7208490355

jhamohan1802@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-AIIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L408||Other psoriasis. Ayurveda Condition: KITIBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Rasamanikya, Reference: Siddha Bhaishajya Manimala 4:66, Route: Oral, Dosage Form: Bhasma, Dose: 60(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -honey), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Arogyavardhini vati, Reference: AFI Part II- 20:4, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Duration: Up to 10 years chronicity

Patients of Plaque Psoriasis

Patients having the clinical features of Kitibhakushtha (mild to moderate Psoriasis) with PASI score up to 10, BSA up to 3 %)

Patients not taking any other Ayurvedic intervention in the last 6 months.

Fresh cases of Kitibhakushtha on prescribtion of Arogyavardhini Vati and Rasamanikya along with Sidharthaka yoga lotion. 
 
ExclusionCriteria 
Details  Patients with severe systemic disorders.

Uncontrolled hypertension, Cardiac diseases, Diabetes mellitus.

Pregnant Women and lactating mothers.

Severe cases of Psoriasis

Patients who are under the Ayurvedic treatment with other formulations 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To assess the levels of mercury and arsenic levels in serum and urine samples of Kitibhakushtha patients during and post-intervention of study drugs
 		 baseline and after 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety of Arogyavardhini Vati & Rasamanikya along with Sidharthaka Yoga
Lotion based on kidney injury biomarkers

 		 baseline & after 12 weeks 
 
Target Sample Size   Total Sample Size="49"
Sample Size from India="49" 
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 
Date of First Enrollment (India)   01/07/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - 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 -  Statistical Analysis Plan
    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 [jhamohan1802@gmail.com].

  6. For how long will this data be available start date provided 27-04-2028 and end date provided 27-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary  

This study is a single arm open labelled  observational study for assessing the serum and urine levels of mercury and arsenic in 55 patients of Kitibha kustha prescribed with Arogyavardhini vati and Rasamanikya (Herbo-mineral preparations) for 3 months with 1 month of follow-up. The primary outcome of the study would provide evidence-based Clinical safety data of Arogyavardhini Vati and Rasamanikya at therapeutic dose levels along with Validation of the Standard manufacturing procedure of study drugs as a secondary outcome.

 
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