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CTRI Number  CTRI/2018/05/014308 [Registered on: 31/05/2018] Trial Registered Retrospectively
Last Modified On: 01/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Panchkarma in Gout 
Scientific Title of Study   CLINICAL EVALUATION OF AMRUTADYA TAIL MATRA BASTI IN THE MANAGEMENT OF VATARAKTA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alok Srivastava 
Designation  Professor 
Affiliation  Uttarakhand Ayurved University 
Address  Dept. of Panchkarma Rishikul Campus Uttarakhand Ayurved University haridwar
do
Hardwar
UTTARANCHAL
249401
India 
Phone  9917098121  
Fax    
Email  virgo.alok@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Kumar Dharua 
Designation  MD Scholar 
Affiliation  Uttarakhand Ayurved University 
Address  Dept. of Panchkarma Rishikul Campus Uttarakhand Ayurved University haridwar
do
Hardwar
UTTARANCHAL
249401
India 
Phone  8763835909  
Fax    
Email  dharuarajeshkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Kumar Dharua 
Designation  MD Scholar 
Affiliation  Uttarakhand Ayurved University 
Address  Dept. of Panchkarma Rishikul Campus Uttarakhand Ayurved University haridwar
do
Hardwar
UTTARANCHAL
249401
India 
Phone  8763835909  
Fax    
Email  dharuarajeshkumar@gmail.com  
 
Source of Monetary or Material Support  
Uttarakhand Ayurved University Dehradun 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Harrawala Dehradun 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alok Kumar Srivastava  Rishikul campus Hospital  Rishikul Campus Uttarakhand Ayurved University Haridwar
Hardwar
UTTARANCHAL 		 9045087121

virgo.alok@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Uttarakhand Ayurved University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Gout, (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Allopurinol Tablet  150 mg BD 
Intervention  Maatra Basti   Amrutadi Taila 50ml though anal route total duration of therapy 60 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Fulfilling Diagnostic Criteria of vatarakta 
 
ExclusionCriteria 
Details  Secondary Hyperuricemia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• Marked improvement : 0% to 25 %
• Moderate improvement : 25 % to 50 %
• Mild improvement : 50% to 75 %
• No improvement : 75% to 100%
 		 • Marked improvement : 0% to 25 %
• Moderate improvement : 25 % to 50 %
• Mild improvement : 50% to 75 %
• No improvement : 75% to 100%
 
 
Secondary Outcome  
Outcome  TimePoints 
• Marked improvement : 0% to 25 %
• Moderate improvement : 25 % to 50 %
• Mild improvement : 50% to 75 %
• No improvement : 75% to 100%
 		 • Marked improvement : 0% to 25 %
• Moderate improvement : 25 % to 50 %
• Mild improvement : 50% to 75 %
• No improvement : 75% to 100%
 
 
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)   30/03/2018 
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)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

AIMS AND OBJECTIVES:

·         The clinical evaluation of AMRUTADHYA TAIL MATRA BASTI in the management of Hyperuricemia.

 MATERIALS AND METHODS:

1.     DRUG REVIEW:

AMRUTADHYA TAIL:

·          गुडूची मधुकं ह्रस्वं..............चैतत्तैलाग्यममृताह्रयम || (च. चि. २९)

·          UkkfLr rSykr ija fdafpnkS’k?ka ek:rkige……………………AA (च. सु . २८)

·         शरीरजानां दोषाणां क्रमेण परमौषधम्

............................तैलं घृतं मधु  (अ० ह्०)

 

Tail is main draya to pacify vata dosh, as described. Here we are using tail in the form of maatra basti.

 

2.     TREATMENT REVIEW :

BASTI :

       Simply it is assume that due to self-etiology Vata gets vitiated and leads to Rakta dusti. Ultimately Rakta forms avarana in channels of Vata and both gets mutually vitiated.

Seats of Vata are mainly larger and smaller joints so; the joints are involved in this condition.

Treatment of Vatarakta described in various texts in mainly Basti Chikitsa.

न हि वस्तिसमं किंचिदवातरक्तचिकित्सितम् ।। (च. चि. २९/८८)4

Different type of Basti described in Ayurvedic text including Niruha Basti, Anuvasana Basti and Matra Basti. So in this study we are taken Matra Basti because of its easy application and administration.

3.     PLAN OF STUDY:

Patients having Hyperuricemia and general symptoms of vata rakta  will be selected from O.P.D/I.P.D of Panchakarma Department, Rishikul Campus, Haridwar. The study will be conducted on the patients randomly distributed into 2 groups of 20 patients in each group, on the basis of inclusion and exclusion criteria depending on the detailed clinical history, physical examination and other necessary investigations irrespective of their caste, creed and gender.

 

 

 

A.    INCLUSION CRITERIA:

 

·         Age >20 yrs. or <60 yrs.

·         Patients having general symptoms of Vata Rakta

·         Serum uric acid >6.0 mg/dl (for Females)

·         Serum uric acid >6.8 mg/dl (for Males)

·         Patient age between 20-60yrs.

·         Patient fit for Basti karma.

 

B.     EXCLUSION CRITERIA:

 

·         Secondary Hyperuricemia.

·         Patient with uncontrolled diabetes.

·         Tophaceous gouty arthritis.

·         Patients with renal impairment.

 

C.    CRITERIA FOR WITHDRAWL:

 

·         Personal matters

·         Inter-current illness

·         Aggravation of complaints

 

D.    SAMPLE SIZE: Patients will be randomly distributed in 2 groups.

GROUP A:

20 Patients of this group will be administered with AMRUTADHYA TAILA-MATRABASTI in 3 sittings of 15day with a gap of 7 day in between.

      GROUP B: 

            20 Patients will be given Allopurinol 150 mg twice a day after breakfast and dinner for a period of 60 day.

E.     TYPE OF STUDY: Open randomized clinical trial.

 

F.     FOLLOW UP: The patients will be followed up at 15th day after the completion of total duration of therapy.

 

G.    STUDY DURATION: Total duration of study including follow up is of 66 days.

CRITERIA FOR EXAMINATION AND ASSESSMENT:

A.    SUBJECTIVE PARAMETERS:

Symptoms of Vata Rakta will be examined and Assessed according to self made severity grading :

1.      Kandu ( Itching)

2.      Daah (burning)

3.      Ruk ( Pain)

4.      Aayam (Streching)

5.      Toda ( tenderness )

6.      Sphurana ( Pulsation)

7.      Aakunchan (contraction)

 

Severity of Symptoms

Absent

Mild

Moderate

Severe

Very severe

Grading

0

1

2

3

4

 

B.     OBJECTIVE PARAMETERS:

     INVESTIGATIONS:

·         S. Uric acid

·         Hb%

·         T.L.C

·         D.L.C

·         E.S.R

·         B. Sugar- Fasting and post prandial

·         B. Urea

·         S. Creatinine

·         Urine analysis- Routine & Microscopic

These investigations will be carried out before, in between and after completion of therapy.

Ø  Subjective and objective parameters will be employed for the assessment of the impact of treatment procedures in the respective group.

Complete remission                                            

100% relief

Markedly improved                                             

71%-99% relief

Moderately improved                                         

41%-70% relief

Mildly improved                                                   

16%-40% relief

Unchanged      

0%-15% relief

Worsened

<0%

Research Proforma:  A detailed research proforma will be prepared incorporating all the points from Ayurvedic as well as modern aspect to study the patients as well as disease.

OBSERVATION:

The observation of patients will be carried out before, during and after completion of treatment. Little addition and exclusion may be done as per necessity of the study.

STATISTICAL ANALYSIS:

To obtain the efficacy of the therapy, appropriate statistical analysis will be carried out by applying following statistical teston available data:

·         For inter group comparision of subjective parameter, Mann & Whitney will be applied.

·         For inter group comparision of objective parameter, Chai square test will be applied.

RESULTS & CONCLUSION:

The results will be analyzed statistically and discussed. Conclusion will be made on the basis of observation which is done on objective parameters.

 
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