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CTRI Number  CTRI/2024/05/067401 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To know the effect of Aralu(Ailanthus excelsa Roxb.) and Shyonaka(Oroxylum indicum Vent.) in the management of swelling  
Scientific Title of Study   Evaluation of Shothahara karma of Aralu(Ailanthus excelsa Roxb.)as an alternative for Shyonaka(Oroxylum indicum Vent.) 
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nakum Payalben Ramjibhai 
Designation  MD scholar 
Affiliation  Institute for post graduate teaching and research in Ayurveda Jamnagar 
Address  Department of Dravyaguna 3rd floor ITRA Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9512469211  
Fax    
Email  payalnakum206@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Bhupesh R Patel  
Designation  Professor and HOD 
Affiliation  Institute for post graduate teaching and research in Ayurveda Jamnagar 
Address  Department of Dravyaguna 3rd floor Room no 329 ITRA Jamnagar GUJRAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  7487876343  
Fax    
Email  brpayu@itra.edu.in  
 
Details of Contact Person
Public Query  
Name  Nakum Payalben Ramjibhai 
Designation  MD scholar 
Affiliation  Institute for post graduate teaching and research in Ayurveda Jamnagar 
Address  Department of Dravyaguna 3rd floor ITRA Jamnagar GUJARAT 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9512469211  
Fax    
Email  payalnakum206@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar-361008 
 
Primary Sponsor  
Name  Nakum Payalben Ramjibhai 
Address  Department of Dravyaguna 3rd floor ITRA Jamnagar GUJARAT 361008 India 
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 Nakum Payal  Institute of Teaching and Research in ayurveda hospital  OPD NO.02 Department of Dravyaguna 3rd floor ITRA Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT 		 9512469211

payalnakum206@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee,Institute of teaching and research in ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R609||Edema, unspecified. Ayurveda Condition: SVAYATHUH/SOTHAH/SOPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Shyonaka, Reference: Charak samhita sutrasthan 4/15, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Aralu, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Patients presenting with the classical signs and symptoms of Shotha with less than 3 months of chronicity.
2.Shotha due to skin diseases, hypothyroidism, hypoproteinemia and generalized anasarca will be included.
 
 
ExclusionCriteria 
Details  1.Patients suffering from any systemic uncontrolled disease like
Diabetes, hypertension, cardiac anomaly,
Chronic renal failure, Liver cirrhosis, filariasis, etc.
2.Pregnant or lactating mother.
3.Patients exhibiting lakshanas of aagantuj Shotha.
4.Patients suffering from any auto immune diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in condition will be assessed based on changes in scoring patterns developed for grading of these clinical factors. on 0th and 14th day.
•Change in the clinical symptoms of General oedema pitting measurement of affected parts on 0th and 14th day.
 		 2 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Change in routine Blood & Urine investigations on 0th & 14th day  14 day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/07/2024 
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 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 - NO
Brief Summary   This trial is randomized clinical trial to evaluate the efficacy of Ailanthus excelsa Roxb. Kwatha in compare to Shyonaka Kwatha in the management of Shotha. selected patients will be divided in to two group on basis of computer generated randomization. in this study both the group will receive drug in dosage of 50 ml Kwatha empty stomach twice a day for 14 days. 
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