Comparision Between Effect Of Trikarshik Kwath And Kokilakshadi Kwath in the treatment of Vatarakta(Gout).

Not yet recruiting

• Conditions: Gout, unspecified. Ayurveda Condition: VATARAKTAM,

• Registration Number: CTRI/2023/06/054411
• Lead Sponsor: Dr Gauri Keni

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.

     Â·       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.

    Â·       *Trikarshik Churna* contains *Guduchi,Shunthi* and *Dhanayak*.Theseingredients are easily available and cost –effective.

·      *Guduchi*causes stimulation of *Dhatvaagni*.Iteliminates *Doshas* and *Kleda*.It is *Kushthaghna,Raktavardhak,Raktashodhak*and does *VedanaSthapan* and *Daha Prashaman*.**12** Accordingto modern Research it has Antirheumatic, diuretic and anti-inflammatoryeffects.

·       *Dhanyak* being *tikta,katu,ushna* does *Amapachan*.Itis *Mutrajanan* and *Mutravirajeenya* due to *Madhur Vipaka* and*Snigdha Guna*. Its *Tikta rasa* excretes *Pitta* contaminatingurine.

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

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

·       There is no substantial researchdone on the usage of *Trikarshik Kwath* for *Vatarakta* hence, thistopic is selected for research work.

·       To fulfill the above needs acontrolled clinical study will be carried out to find the efficacy of *TrikarshikKwath* in *Vatarakta* with special reference to gout.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-07
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
decrease in the sign & symptoms of vatarakta(gout)	21 days

Trial Locations

Locations (1)

D Y Patil School of Ayurveda; 🇮🇳 Thane, MAHARASHTRA, India

D Y Patil School of Ayurveda

🇮🇳Thane, MAHARASHTRA, India

Dr Gauri Keni

Principal investigator

8422025172

keni.gauri115@gmail.com