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CTRI Number  CTRI/2023/06/054411 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 23/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Randomized controlled trial]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision Between Effect Of Trikarshik Kwath And Kokilakshadi Kwath in the treatment of Vatarakta(Gout). 
Scientific Title of Study   A Comparative Clinical Study to evaluate the efficacy of Trikarshik Kwath and Kokilakshadi Kwath in Vatarakta With Special reference to Gout.  
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 Gauri Keni 
Designation  PG Scholar 
Affiliation  D.Y.Patil Deemed to be university school of Ayurveda nerul navimumbai 
Address  D.Y. Patil Deemed to be University School of Ayurveda,1st Floor Department of Kayachikitsa, opd no 1,Sector 7,Nerul,Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  8422025172  
Fax    
Email  keni.gauri115@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpana Satpute 
Designation  Associate Professor Department of Kayachikitsa 
Affiliation  D.Y.Patil Deemed to be university school of Ayurveda nerul navimumbai 
Address  D.Y. Patil Deemed to be University School of Ayurveda,3rd Floor Department of Kayachikitsa,Sector 7,Nerul,Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9890486825  
Fax    
Email  drkalpana2005@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalpana Satpute 
Designation  Associate Professor Department of Kayachikitsa 
Affiliation  D.Y.Patil Deemed to be university school of Ayurveda nerul navimumbai 
Address  D.Y. Patil Deemed to be University School of Ayurveda,3rd Floor Department of Kayachikitsa,Sector 7,Nerul,Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9890486825  
Fax    
Email  drkalpana2005@rediffmail.com  
 
Source of Monetary or Material Support  
D Y Patil Deemed to be University School of Ayurveda and Hospital Sector 7 Nerul Navi Mumbai 400706 
 
Primary Sponsor  
Name  Dr Gauri Keni 
Address  D Y Patil Deemed to be University School of Ayurveda and Hospital Sector 7 Nerul Navi Mumbai 400706 
Type of Sponsor  Other [Self] 
 
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 Gauri Keni  D Y Patil School of Ayurveda  D Y Patil Deemed to be university school of ayurveda ,1st floor ,opd no 1,department of kayachikitsa sector 7, nerul, navi mumbai
Thane
MAHARASHTRA 		 8422025172

keni.gauri115@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kokilakshadi kwath, Reference: yogratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Trikarshik kwath, Reference: Chakradatta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Patients fulfilling the criteria of Vatarakta (uttan-gambhir and doshaj) having signs and symptoms such as Sandhi Toda,Vidaha,Sparsha Asahatva, Twak Vaivarnya, Sandhi Shotha, Sandhi Vikriti.
2.Patients having increased uric acid levels(hyperuricemia-males-above 7.0mg/dl and females -above 6.0mg/dl)
3.Patients will be selected irrespective of sex ,religion,socioeconomic status.
4.Patients willing to give signed informed consent. 
 
ExclusionCriteria 
Details  1. Amavat(RA),Sandhigata vata(Osteo-Arthritis), Renal disease,SLE
2. Known case of tuberculosis (Pulmonary and Extra Pulmonary).
3. Patients having history of malignancy,HIV,Trauma, Severe or Acute Cardiac diseases associated with Gout.
4. Chronic joint deformity.
5. Pregnant and lactating women.
6. Hypersensitive reaction to any drug.
7. Patient with autoimmune disease of joint.
8. High risk, comorbid patients suspected for covid 19 as per ICMR guidelines.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
decrease in the sign & symptoms of vatarakta(gout)  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   N/A 
Date of First Enrollment (India)   03/07/2023 
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  

TITLE OF DISSERTATION

A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF TRIKARSHIK KWATH AND KOKILAKSHADI KWATH IN VATARAKTA WITH SPECIAL REFERENCE TO GOUT

INTRODUCTION-

Vatarakta is a disease of Madhyam Roga Marga as it affects mainly Asthi Sandhis. Till now we correlate Vatarakta with Gout. Gout is a clinical syndrome characterized by inflammatory response of musculoskeletal tissues to monosodium urate crystals in those with elevated serum uric acid (>7.0mg/dl) called as hyperuricemia.

NEED OF STUDY-

Goal of any treatment should be symptom relief, disease control and finally the patient’s wellbeing. Also, the drug used should be cost effective, easily available and has no or minimal side effects.Therefore, there is a definite need to explore more efficacious cure to this illness via Ayurveda.

AIM:

1.      TO COMPARE THE EFFICACY OF TRIKARSHIK KWATH AND KOKILAKSHADI KWATH IN VATARAKTA WITH SPECIAL REFERENCE TO GOUT.

OBJECTIVES:

1.      To study Vatarakta in Ayurvedic aspect.

2.      To study Gout in modern aspects.

3.     To evaluate the efficacy of Trikarshik Kwath and Kokilakshadi Kwath in Vatarakta.

4.     To compare the effects of both drugs in management of Vatarakta.

5.     To study different references of Vatarakta and Gout from authentic texts and Scholarly Journals like Scopus,Pubmed,etc.

       DRUGS-

·       Group A - (Trial Group) Trikarshik Kwath-{Guduchi,Shunthi,Dhanyak}

       Reference - Chakradatta(Sanskrit text with English translation) edited and translated by P V Sharma, Vatarakta  Chikitsa  Adhyay 23/4,  Kashi Ayurved Series-17,pg 215

        


·       Group B – (Control Group) Kokilakshadi Kwath-{Kokilaksha,Guduchi }  

        Reference- Yogratnakar Vol 1 edited and translated by Dr Madham Shetty and Suresh Babu, Vatarakta Adhyay, ,Choukhambha Sanskrit series,Varanasi, pg 659

       

SOP-

Kwath will be prepared as per reference given in Sharangdhar Samhita Madhyamkhanda Adhyay 2, Shlok No. 1 and 2. Here Acharya has advised to take ingredients in Bharad or Churna 1 part of churna in 16 parts of water, which is reduced to 1/8th part of liquid after cooking on low flame.Similarly, as we are giving 60 ml in 2 divided doses,for the convenience ,total Churna will be taken 15gms and 16 parts of water(240ml) which will be reduced to 1/8 th part(30ml) .Kwath of 30ml will be formed.so freshly prepared kwath is used both times.

DOSE: 30 ml twice a day after food with warm water for 21 days for both drugs.

Type of study:

 Interventional Study

Study Design

1.      Two armed

1.     Open labelled

2.     Randomized

3.     Prospective

4.      Controlled clinical study

Sample size:

60 patients will be selected (30 of trial group A and 30 of controlled group B) also written informed consent will be taken from each patient.

Place of study:

O.P.D and I.P.D of D.Y. Patil Ayurvedic hospital and Medical Camps held by the Institute.

Duration of study: 21 days

Analytical study of Drug-

Authentification and standardization of Drug will be carried out at authentic pharmaceutical Laboratory.

Quality control analysis will be done at the same laboratory.

Patients having classical signs and symptoms of Vatarakta w.r.t Gout with increased Sr. Uric Acid level.

GROUP

A (Trial Group)

B (Control Group)

SAMPLE SIZE

30

30

DRUG

Trikarshik Kwath

Kokilakshadi Kwath

DOSE

30 ml BD

30 ml BD

KAAL

Vyanodaan (BD After food)

Vyanodaan (BD After food)

ROUTE OF ADMINISTRATION

Oral

Oral

ANUPANA

Koshna jala

Koshna jala

DURATION

21 Days

21 Days

 

ASSESSMENTS

Day-1st,7th , 14th ,21st

Day-1st,7th , 14th ,21st

 

DIAGNOSTIC CRITERIA:Patients having classical signs and symptoms of Vatarakta w.r.t Gout with increased Sr. Uric Acid level

OBJECTIVE CRITERIA:

Serum Uric Acid will be done in the initiation of the study and at the completion of the study.

URIC ACID LEVEL CHART

Uric Acid Level

Males

Females

Normal

2.5-7.0mg/dl

1.5-6.0mg/dl

High

Above 7.0mg/dl

Above 6.0mg/dl

 

SUBJECTIVE CRITERIA:

SR

NO

SYMPTOM

GRADE-0

GRADE-1

GRADE-2

GRADE-3

1

Sandhi Toda

(Pain in joints)

No pain in rest and working

Mild pain with no difficulty in working

Moderate pain with difficulty in walking

Severe pain with difficulty in walking

2

Vidaha (Burning sensation)

No

Mild

Moderate

Severe

3

Sparsha Asahatva

(Tenderness)

No pain on palpation

Mild pain on palpation

Moderate pain on palpation

Patient does not allow to palpate

4

Twak Vaivarnya

(Discoloration)

 

No

Mild

Moderate

Severe

5

Sandhi Shotha(Swelling)

No

Mild

Moderate without loss of movements

Severe with loss of movements

6

Sandhi Vikriti (Deformity)

No Deformity

Mild deformity of single joint

Moderate deformity of 2-5 joints

Formation of tophi in multiple joints

7

Status of pain on Movement of Joint

Minimal pain with Active Joint Movement

Moderate pain with Passive Joint Movement

Severe pain with Lesser Joint Movement

Severe Pain with No Joint Movement

8

Raga (Redness)

No

Mild

Moderate

Severe

 

ASSESSMENT CRITERIA:

 

SUBJECTIVE

Markedly improvement

>76% or<100% relief in sign & Symptoms

Moderate improvement

>51% or < 75% relief in sing & Symptoms

Mild improvement

>26% or <50% relief in sing & Symptoms

No improvement

<25% relief in sign & Symptoms

 

LABORATORY INVESTIGATIONS:

·       Serum Uric Acid

·       RFT

·       LFT

      Conclusion will be drawn on the basis of statistical analysis with all the data collected. It will prove or disprove the research hypothesis.

       Backgroung and purpose of trial:

·       A number of Epidemiological studies from diverse range of countries suggest that gout has increased in prevalence over the last few decades.

     

·       Normally Analgesics, Uric acid reducer, non-steroidal anti-inflammatory drugs (NSAIDs), Anti-inflammatory, colchicine and glucocorticosteroid are used to treat gout which has its own limitations and adverse effects like skin rashes, diarrhea and nausea. Among the drugs used are Allopurinol which can cause hypersensitivity reactions and target serum uric acid levels are not always achieved. Also Febuxostat which is first major treatment given now-a-days alternative to Allopurinol which has side-effects like liver function abnormalities,dizziness,arthralgia,nausea,rash. Benzbromarone can cause liver toxicity, risk of uric acid stone formation.NSAIDs can cause gastro-intestinal side effects and renal effects.Glucocorticosteroids can cause detoriation of diabetic metabolism in diabetes mellitus,high blood perssure,raised blood sugar, osteoporosis and gastro-intestinal side-effects.

·       Disadvantages of uricosuric agents are over production of uric acid and gross uricosuria, patients with renal failure, presence of urate urolithiasis in gout.

    

·       Trikarshik Churna contains Guduchi,Shunthi and Dhanayak.These ingredients are easily available and cost –effective.

·       Guduchi causes stimulation of Dhatvaagni.It eliminates Doshas and Kleda.It is Kushthaghna,Raktavardhak,Raktashodhak and does VedanaSthapan and Daha Prashaman.12 According to modern Research it has Antirheumatic, diuretic and anti-inflammatory effects.

·       Dhanyak being tikta,katu,ushna does Amapachan.It is Mutrajanan and Mutravirajeenya due to Madhur Vipaka and Snigdha Guna. Its Tikta rasa excretes Pitta contaminating urine.

·       Shunthi does Sheet-Prashaman, Vedana-Sthapan. It is Shothahar,VataShamak,RaktaShodhak.It has Protein-Vishleshak Tatva.It is good Ama-Pachak.It digests the Ama and cures many Ama Pradoshaja Lakshana/disorders. Due to its Tikshna property, it destroys Strotorodha.

·       The goal of treatment is to diminish the stored uric acid crystal deposits and thereby to prevent the inflammatory process that they cause, which leads to structural alterations.

·       There is no substantial research done on the usage of Trikarshik Kwath for Vatarakta hence, this topic is selected for research work.

·       To fulfill the above needs a controlled clinical study will be carried out to find the efficacy of Trikarshik Kwath in Vatarakta with special reference to gout.

 

 
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