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CTRI Number  CTRI/2022/10/046120 [Registered on: 03/10/2022] Trial Registered Prospectively
Last Modified On: 30/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparative Study of the Efficacy of Vasaadi Kwath (decoction of Vasa and other herbs) and Raktamokshan (bloodletting) by Sira Vedhan (puncturing the vein) in the Management of Vatarakta W.S.R. to Gout (joints disorder of disturbed metabolism) 
Scientific Title of Study   A Comparative Study of the Efficacy of Vasaadi Kwath and Raktamokshan by Sira Vedhan in the Management of Vatarakta W.S.R. to Gout 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankit Saini 
Designation  PG Scholar 
Affiliation  Shri krishna Govt. Ayurvedic College& Hospital 
Address  Room no. - 102 PG Department of Shalya tantra, Shri Krishna Govt Ayurvedic College and Hospital sec -8 , Umri road Kurukshetra HARYANA 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  8168296964  
Fax    
Email  ankitsaini094@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajender Singh 
Designation  Associate Professor 
Affiliation  Shri krishna govt ayurvedic college and hospital 
Address  Room no. - 102 PG Department of Shalya tantra, Shri Krishna Govt Ayurvedic College and Hospital sec -8 , Umri road Kurukshetra HARYANA 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  9416662761  
Fax    
Email  drrajendersingh1346@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ankit Saini 
Designation  PG Scholar 
Affiliation  Shri krishna Govt. Ayurvedic College& Hospital 
Address  Room no. - 102 PG Department of Shalya tantra, Shri Krishna Govt Ayurvedic College and Hospital sec -8 , Umri road Kurukshetra HARYANA 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  8168296964  
Fax    
Email  ankitsaini094@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna AYUSH University  
 
Primary Sponsor  
Name  Shri Krishna AYUSH University Kurukshetra  
Address  Umri road, Sector 8, Kurukshetra - 136118  
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 Ankit Saini  Shri Krishna Govt. Ayurvedic College & Hospital   Room no. 103, pg department of shalya tantra, shri krishna govt. Ayurvedic college & hospital Umari Road Sector 8 Rewari HARYANA
Kurukshetra
HARYANA 
8168296964

ankitsaini094@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: vasaadi kwath, Reference: bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: , Procedure details: Raktamokshan by Siravedhan will be done on 1st, 7th ,14th and 21. Follow-up will be done on every 7th day)
3Comparator ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: sushruta samhita, Procedure details: Raktamokshan by Siravedhan will be done on 1st, 7th ,14th and 21. Follow-up will be done on every 7th day)
(1) Medicine Name: vasaadi kwath, Reference: bhavprakash, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 21 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with clinical features of Vatarakta
2. Patients of either sex
3. Patients having age group of 25-65 years.
4. Willingness of patients for study
5. Patients having serum uric acid level >7.0 mg/dl in male and >6.0 mg/dl in females. 
 
ExclusionCriteria 
Details  1. Age below 25 years & above 65 years
2. Uncontrolled Diabetes mellitus, hypertension, COPD
3. Known case of any type of Tuberculosis &HIV Patients
4. HBsAg AND HCV Positive patients
5. Anemia (hemoglobin <7.00mg/dl), jaundice
6. Pregnancy
7. Leukemia
8. Patients unwilling to participate in the trial
9. Paralysis
10. Known case of any blood disorder like sickle cell anemia, Thrombocytopenia etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Sandhishool
2. Sandhishoth
3. SparshaAshtava
4. Raga
5. TwakVaivarnya
6. Stabdhta
7. Vidaha
8. Levels of uric acid
 
At 1st, 7th, 14th & 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Sandhishool
2. Sandhishoth
3. SparshaAshtava
4. Raga
5. TwakVaivarnya
6. Stabdhta
7. Vidaha
8. Levels of uric acid 
At 1st, 7th, 14th & 21st day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   03/10/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Ayurveda the “Science of life” or longevity is the holistic alternative science since era. The whole philosophy of Ayurveda is based on achieving, maintaining and prompting positive health. The equilibrium of various structural and functional units of body namely doshas, dhatu, mala, agni, indriya, atma and mann results in a healthy body. Vatarakta is a disease which is encountered in the population leading to sedentary life style.

The description of Vatarakta is found in Brihattrayi and other classical books also. Acharya Charak includes Vatarakta in raktajroga in rakta dustijanyavikara[1] and also give its whole description as a separate diseases entity in chikitsasthan. In Shushrut Samhita it is described in vatavyadhi adhyaya. The factor said in the classics which are responsible for Vatarakta is virudhahara and mithya vihara.[2] These leads to the vitiation of vayu and rakta aggravated, Vata paves for vitiation of rakta in turn leading to further aggravation of Vata thus evolves condition Vatarakta. In Charak Samhita synonyms of Vatarakta is khudd, vatablas, adhyavata.[3] Because it occurs mostly in rich person due to an inappropriate relationship with their environment.

In modern medical sciences the characteristics of Vatarakta resemble with those of Gout therefore it can be better correlated to Gouty arthritis.

GOUT is an abnormality of purine metabolism that causes hyperuricemia and deposition of monosodium urate crystal in Joints-acute Gouty arthritis, In soft tissues-causing tophi and tenosynovitis, In renal tubules-causing urate stones and urate nephropathy.[4]

While talking about treatment of Vatarakta Acharya Sushrut advised to perform Raktamokshan repeatedly [5]

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Acharya Sushrut explained the shastiupkarma and described raktavisravana is very useful in vedanaupshamna and to relieve achirottitashopha.[6]

Acharya Sushrut consider rakta as a fourth dosha.[7] Expulsion or removal of vitiated rakta as well as other vitiated doshas from the body is called Raktamokshan. Amongest various methods of Raktamoshana like shring, jalauka, alabu and Siravedhan. Among these Siravedhan is more effective and quicker in action. Siravedhan has been one of the most commonly used therapeutic procedure to remove the vitiated blood with the help of sharp instruments and is specially used to treat sarvangagata raktadustijanya vikara. It relieves pain and redness immediately and considered as “Ardhchikitsa” in Shalya tantra.[8]

Acharya Bhavparkash advised to use Vasaadi kwath to alleviate Vatarakta completely.[9]

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The decoction prepared with Vasa, Guduchi, and Amaltas mixed with Erandtaila should be given to alleviate generalized Vatarakta.

In this research the authors are proposed to analyze the efficacy of Vasaadi kwath and Raktamokshan by Siravedhan for treatment of Vatarakta.

 

NEED FOR THE STUDY             

Due to the remittent and relapsing nature of Vatarakta (Gout), there is no permanent cure for the diseases, which is a challenge in present era. Moreover, it is a potential signal for unrecognized co-morbidities like metabolic syndrome, Diabetes mellitus, coronary artery diseases and hypertension.

Although several drug regimens have been advised for its management in modern science like NSAIDS, Colchicine, Corticosteroids and Hypouricemic drugs, there use is associated with adverse effects and certain limitations.

Therefore, it is essential to find out some alternative therapeutics based on herbs Vasaadi kwath and Para-surgical procedure i.e Siravedhan in the management of Vatrarakta (Gout).

 
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