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CTRI Number  CTRI/2025/06/088989 [Registered on: 17/06/2025] Trial Registered Prospectively
Last Modified On: 17/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic management of vata rakta(Gout) by Siravedhana and Mustadi Yapana Basti 
Scientific Title of Study   A Randomized Comparative Clinical Study Evaluating the Efficacy of siravedhana followed by Modified Bala Guduchyadi Yapana Basti and Mustadi Yapana Basti in the Management of Vatarakta wsr 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 Vikas 
Designation  PG Scholar 
Affiliation   
Address  Room No. 203, Department of Panchakarma, Parul Institute of Ayurved, Parul University,PO Limda,Ta Waghodia 391760, Vadodara, Gujarat, India
Room No. 203, Department of Panchakarma, Parul Institute of Ayurved, Parul University,PO Limda,Ta Waghodia 391760, Vadodara, Gujarat, India
Vadodara
GUJARAT
391760
India 
Phone  7533088547  
Fax    
Email  vikaspandit0007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangeeta H Toshikhane 
Designation  Professor and HOD of Panchakarma 
Affiliation  Parul institute of ayurved  
Address  Department of Panchakarma, Parul Institute of Ayurved, Parul University,PO Limda,Ta Waghodia 391760, Vadodara, Gujarat, India

Vadodara
GUJARAT
391760
India 
Phone  9964596479  
Fax    
Email  sangeeta.toshikhane26791@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sangeeta H Toshikhane 
Designation  Professor and HOD of Panchakarma 
Affiliation  Parul institute of ayurved  
Address  Department of Panchakarma, Parul Institute of Ayurved, Parul University,PO Limda,Ta Waghodia 391760, Vadodara, Gujarat, India

Vadodara
GUJARAT
391760
India 
Phone  9964596479  
Fax    
Email  sangeeta.toshikhane26791@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul Institute of Ayurveda, Parul University, PO Limda, Ta Waghodia 391760, Vadodara, Gujarat 
 
Primary Sponsor  
Name  Parul Institute of Ayurveda 
Address  Parul University PO Limda Ta Waghodia 391760 Vadodara Gujarat 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 Vikas  Parul Ayurved Hospital  Panchakarma OPD no 105 and Panchakarma IPD, Parul Ayurved Hospital, Parul University, Limda, Vadodara.
Vadodara
GUJARAT 
07533088547

vikaspandit0007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Human Research Parul Institute of Ayurveda Parul University  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 ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म Pradhan Karma(Procedure Reference: Charak Samhita, Vol. 1, Charak Samhita, Siddhi Sthana, Chapter 12/16-1, Chaukhamba Sankrit Pratishthana, pg. 181., Procedure details: Basti Yapan basti will be done for 8days Basti Poorva karma: Patient should be lie on left lateral position, extending the left lower limb & flex the right lower limb at knee & hip. Pradhan karma:Basti Netra is to be gently introduced into the anus & the Putaka is to be pressed slowly to administer basti dravya while patient is advised to breathe deeply through the mouth.Basti Netra is withdrawn with a small amount of medicament left in the Putaka to avoid air entry. Paschat karma: patient is asked to lie in a supine position until the urge to defecate occurs & to clear the bowels as many times as needed followed by rest & warm meal )
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charak Samhita 12/16, Procedure details: Purvakarma- Selection of the patient, counselling of the patient, basti preparation Pradhana Karma- Modified Bala guduchyadi yapana Basti administration at Nati-kshudharta state Paschat Karma- Rest, snana, laghu bhojana advised, basti pratyagamana kala and number of vega will be noted)
(1) Medicine Name: Murchhita go ghrita, Reference: Bhaishajya Ratnawali, Route: Rectal, Dosage Form: Ghrita, Dose: 50(ml), Frequency: od, Duration: 8 Days
(2) Medicine Name: Mustadi Ksheer Paka , Reference: Charak Samhita, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 350(ml), Frequency: od, Duration: 8 Days
(3) Medicine Name: Bala Guduchyadi Kashay, Reference: Sushruta Samhita chi. , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 350(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects presenting with classical clinical features of Vatarakta.
2. Subjects of either gender between age group of 18-70 yr.
3. Subjects fit for Niruha and Anuvasna basti karma.
4. Uric Acid level ABove 6 mg /dl in female.
5. Uric acid level ABove 7 mg/dl in male.
 
 
ExclusionCriteria 
Details  1. Subjects with chronic autoimmune disease of joints & with joint deformity due to it
2. Subjects with uncontrolled metabolic systemic disorder like HTN and DM
3. Pregnant and lactating women.
4. Subjects contraindicated for Niruha and Anuvasana Basti.
5. Subjects with Alpa bala. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in symptoms of Vatarakta  4th day of treatment- first follow up and assesment of parameters
20th day of treatment- second follow up and assesment of parameters 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in uric acid levels  4th day of treatment- first follow up & assesment of parameters
20th day of treatment- second follow up & assessment of parameters 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/07/2025 
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)  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  

Introduction

Vatarakta (Gout) is a complex form of inflammatory arthritis characterized by recurrent episodes of intense pain, swelling, and redness in the affected joints, most commonly the big toe. This condition arises from the accumulation of monosodium urate crystals in the synovial fluid, a consequence of hyperuricemia. In Ayurveda, we can co-relate to  Vatarakta, a vyadhi caused by the imbalance of Vata and Rakta. When aggravated Vata is blocked by vitiated Rakta, leading to further aggravation of Vata. Vatarakta has two stages: Uttana (mild) which primarily affects the twak, rakta, and mamsa while gambhira vatarakta affects deeper tissues such as asthi, sandhi and snayu, often described as more severe and persistent. It is considered a serious disease, with severe joint pain being the most prominent symptom and affects the hands and feets later on spreading to other joints. This pain can significantly disrupt daily life, making it difficult for individuals to use the affected joints. Ayurveda offers treatment options for Vatarakta, including Shodhana (purification therapies), Shamana (palliative medicines), and Rasayana (rejuvenation therapies). Given this context, there is a need for research to evaluate the efficacy of Raktamokshana along with modified bala guduchyadi yapana basti  and mustadi yapana basti  in managing Vatarakta.

Need of the study:

 Ayurvedic Management of Vatarakta (Gout) with Siravedhana and Yapana Basti: A Holistic Approach Gout, a metabolic disorder characterized by elevated uric acid levels and painful joint inflammation, is increasingly prevalent worldwide, with a global prevalence of 1–4% and incidence of 0.1–0.3%. It commonly coexists with conditions such as hypertension, cardiovascular disease, obesity, and diabetes. Men are disproportionately affected compared to women (3:1 to 10:1). Despite its growing burden, modern medicine lacks a definitive long-term management protocol, especially for recurrent familial cases.

In Ayurveda, gout correlates with Vatarakta, a condition involving the vitiation of Vata and Rakta. Treatment focuses on both Shodhana (purification) and Shamana (palliation) therapies. Among the Shodhana therapies, Siravedhana (therapeutic bloodletting) plays a crucial role. It helps in directly removing Dushta Rakta (vitiated blood) along with Ama (toxins) and excess Pitta, thereby detoxifying the circulatory system. This elimination process helps to unblock the Rakta Vaha Srotas (blood channels), reduce systemic inflammation, and restore Agni (digestive fire), reducing further toxin accumulation.

Another key treatment is Yapana Basti (medicated enema), which is both Rasayana (rejuvenative) and Vata-pacifying. Unlike aggressive purgative Bastis, Yapana Basti nourishes and strengthens the body while gently balancing Vata. It plays a significant role in mitigating pain, stiffness, and other Vata-related symptoms of Vatarakta. It also supports the regeneration and nourishment of Dhatus (tissues), particularly Rakta Dhatu, promoting long-term recovery of affected joints and muscles.

Modified Mustadi Yapana Basti and Bala Guduchyadi Yapana Basti are specific formulations used in Vatarakta. Musta (Cyperus rotundus) is known for its anti-inflammatory and Ama-pachana actions, while Guduchi (Tinospora cordifolia), especially when processed with milk (Ksheera), offers immunomodulatory, anti-inflammatory, and tissue-rejuvenating benefits. Bala (Sida cordifolia) adds a strengthening effect, further supporting tissue repair and vitality.

This combined approach—Siravedhana followed by specific Yapana Bastis—offers a comprehensive Ayurvedic protocol to address the root pathology of Vatarakta. These therapies work synergistically to detoxify, nourish, and restore balance, ultimately improving joint function, relieving pain, enhancing strength, and boosting Ojas (vital energy).

Despite promising clinical outcomes, there is a lack of systematic, evidence-based studies evaluating the combined efficacy of Siravedhana and these Basti formulations in Vatarakta. The current study aims to fill this gap by assessing therapeutic effects through standardized clinical tools such as Visual Analogue Scale (VAS), Range of Motion (ROM), and symptom scoring.

A well-designed, evidence-backed Ayurvedic protocol for Vatarakta can serve as an effective alternative or adjunct to conventional treatments, offering safe and holistic care for patients suffering from this chronic and debilitating disease.

 

Review of literature:

Charaka Samhita

Charaka Samhita, Chikitsa sthana, 29th chapter

Sushruta Samhita, 5th chapter of chikitsa sthana

Bhaisajya ratnavali  5th chapter

Aim:

To study the Shodhana effect of Siravedhana followed by Modified bala guduchyadi yapana basti  and mustadi yapana basti in the management of vatarakta w.s.r to Gout

Objectives:

1.     To study the efficacy of Siravedhana followed by Bala guduchyadi yapana basti in the management of vata rakta

2.     To study the efficacy of Siravedhana followed by Modified mustadi yapana basti in the management of vata rakta

3.     To compare the efficacy of Siravedhana followed by mustadi yapan basti and bala guduchyadi yapana basti in the management of vata rakta.

4.     To observe the shodhana effect of Siravedhana.

5.     To observe and evaluate the rehabilitation efficacy of yapana basti in vatarakta patients.

Research Question:

Is Siravedhana followed by Modified Bala Guduchyadi yapana basti and Mustadi yapan basti effective in management of vatarakta?

Hypothesis:

Null Hypothesis(H0): Neither Siravedhana followed by Modified bala guduchyadi yapana basti nor Siravedhana followed by mustadi yapana basti is effective in management of vatarakta.

Alternate hypothesis:

(H1) Siravedhana followed by modified bala guduchyadi yapana basti is effective in the management of vatarakta.

(H2) Siravedhana followed by mustadi yapana basti is effective in management of vatarakta.

(H3) Siravedhana followed by modified mustadi yapana basti and bala guduchyadi yapana basti are effective in the management of vatarakta.

Materials

1. Source of data:

A). Literary source:- All the available classical, modern literature and contemporary text including the journals and online websites regarding the vata rakta basti karma, siravedhana and gout will be reviewed and documented for the study.

B). Pharmaceutical source:- All raw drugs will be purchased from registered shops/store. Preparation of drug will be done in GMP certified pharmacy.

C). Clinical source:-Patients diagnosed with vatarakta will be selected from OPD and IPD of Parul Ayurved Hospital, Limda, Vadodara, Parul Sevashram Hospital, Vadodara.

Methodology:

Sample size - 20

Study design  :  Randomized Comparative clinical study pre and post assessment.

Study duration: 18 months

Follow up : 3 Follow ups, one on zero day, second follow up on 4th day and 3rd follow up on 20th day.

Duration of treatment: 12 Days

Selection Criteria: 20 Patient will be selected from OPD and IPD of Parul Ayurveda Hospital, Parul University and various Health Checkup Camps

Screening investigation

Hb,ESR,RBS,Serum Uric acid,CBC,CRP

Inclusion Criteria: -Subjects presenting with classical clinical features of Vatarakta., of either gender between age group of 18-70 year, fit for Niruha and Anuvasna basti karma with serum Uric Acid level above 6 mg /dl in female and above 7 mg/dl in male.

Exclusion criteria: Subjects with chronic autoimmune disease of joints & subsequent joint deformity, with uncontrolled metabolic systemic disorder like HTN and DM, pregnant and lactating women, those contraindicated for Niruha and Anuvasana Basti and having  Alpa bala.

Diagnostic Criteria

On the basis of classical clinical sign and symptoms we diagnosed the case as Vatarakta

 

Assessment criteria

1.     Subjective Criteria-Sandhishula, Daha, Sandhisotha, Sparshaasahatva, Twak lohita and Visual analog scale

Sln.

Sandhishoola

Grade

1

No Pain

0

2

Mild Pain

1

3

Moderate

2

4

Severe Pain

3

Sln.

Sparshshashatva

Grade

1

No Tenderness

0

2

Pt. Say Tenderness

1

3

Winching Of Face On Touch

2

4

Does Not Allow To Touch

3

Sln

Colour Of Joint

Grade

1

Normal Skin Colour

0

2

Red Colour

1

3

Brown Colour

2

4

Black Colour

3

Sln

Swelling

Grade

1

No Swelling

0

2

Mild Swelling 0-3mm

1

3

Moderate Swelling / Shiny 3-6mm

2

4

Severe Swelling / Redness 6mm

3

2.     Objective criteria

S. No

Serum uric acid

LAB Value mg/dl female

LAB value mg/dl male

Grade

1

Normal

0-6

0-7

0

2

Mild

6.1-7

7-8

1

3

Moderate

7.1-8

8

2

4

Severe

8 and Above

8 and above

3

ROM (Range of movement)

Upper Limb

Lower Limb

Shoulder – Flexion, Extension, Abduction, Adduction, Medial rotation and lateral Rotation

 

Hip -Flexion, Extension, Abduction, Adduction, Medical Rotation and Lateral Rotation

Elbow - Flexion and Extension

Knee - Flexion and Extension

Radioulnar- Supination, Pronation

Ankle - Plantar Flexion and Dorsal Flexion

Wrist - Extension, Radial Deviation, Ulnar Deviation

Sub Talar joint - Inversion, Eversion

Intervention:- 20 Patients of vatarakta fulfilling the inclusion criteria will be randomly selected and assigned into following 2 groups:-

 

Group

Number of patients

Treatment

Group A

10 Patients

Siravedhana followed by Modified mustadi yapana basti

Group B

10 Patients

Siravedhana followed by modified Bala guduchyadi yapana basti

 

Treatment protocol

 

DAY

                  GROUP A

                    GROUP B

For 1-2 days

After achieving Nirama lakshanas Sadyo snehapana with murchita go-ghrita (acc. to agnibala)

After achieving Nirama lakshanas Sadyo snehapana with murchita go-ghrita (acc. to agnibala)

3rd day

Sarvanga abhyanga with pinda taila followed by nadi swedana

Tila yavagu pana 50 -150 ml approx) and Siravedhana – as per Bala of patient

 

4th  day (after achieving nirama lakshanas)

5th day- 12th day

Modified mustadi yapana basti

Modified bala guduchyadi yapana basti

 

Basti karma schedule

 

Day1

Day2

Day3

Day 4

Day 5

Day 6

Day 7

Day 8

Y.B

Y.B

Y.B

Y.B

Y.B

Y.B

Y.B

Y.B

 

Modified Mustadi Yapana Basti

Saindhava Lavana

12gm

Sneha

Murchita Go-Ghrita = 50ml

Kalka

Madanphala, Shatapushpa, Kutaja, Priyangu=20gm

Kwatha

Mustadi Ksheer Paka = 350ml

(Musta, bala, Aragvadha, rasna, manjistha, Punarnava, bibhitaki, bruhati)

Total = 512ml

 

Modified Bala guduchyadi yapana basti

Madhu

80ml

Saindhava lavana

12gm

Sneha

Murchita Go-Ghrita 50ml

Kalka

Bala, Eranda, Manjistha, Nimba, Punarnavadi= 20gm

Kwatha

Guduchyadi ksheer paka = 350ml

(Guduchi, bala, Dashmool, Rasna

Total 512ml

 

SOPs

Siravedhana Karma

Purvakarma

Pradhana karma

 

Paschat karma

 

• Written consent for the procedure will be taken

*  Sadyo Snehapana will be given to the patient for 1- 2 days  

On the 3rd day and 4th day, Sarvanga abhyanga with pinda taila followed by nadi swedana and pitta prakopaka ahara is advised to the patient.

* Tila Yavagu pana(Utkleshanarth Yavagu) will be given on the day of Siravedhana before main procedure.

* Vital checking prior to procedure.

 

• Patient made to sit or lie down comfortably.

* Patient eye will be covered with eye pad/cloth.

 • Apply a tourniquet tightly above the site of punctured; the area is cleaned with spirit and cotton.

* The nearest vein is select according to effected side to be punctured.

* The needle is to be inserted into the desired vein.

* The blood is collected in beaker.

 

• When blood flow reduces, remove the tourniquet.

* Clean the site and apply bandage over the punctured area.

 • The patient is advised to rest for 15-20 minutes.

 

 

Basti

          Poorvakarma

      Pradhanakarma

       Paschatkarma

Counselling of the Patient, Basti Preparation.

 

 

Bgb – Selection of The Patient, Counselling of The Patient, Basti Preparation.

 

 

 

 

 

Modified Mustadi Yapana Basti Administration at Na ati-Kshudharta State.

 

Bgb – Modified Bala Guduchyadi Yapana Basti Administration at Na ati-Kshudharta State

 Rest, Snana, Laghu Bhojana Advised, Basti Pratyagamana Kala and Number of Vega Will Be Noted.

Bgb – Rest, Snana, Laghu Bhojana Advised, Basti Pratyagamana Kala and Number of Vega Will Be Noted.

STASTICAL ANALYSIS: Collected data and observation will be analyzed critically and scientifically by employing statistical tests.

ETHICAL CLEARANCE:  Ethical clearance will be obtained from Institutional Ethics Committee before starting the study and this study will be registered in the Clinical Trial Registry of India.

DECLARATION : Study will be completed in stipulated time.

CRITERIA OF WITHDRAWAL 

 Cases included in study will be withdrawal from the study if they develop any complication and such cases will be referred to concerned consultant for further management. 

REPORTING OF ADVERSE DRUG REACTION TO PHARMACOVIGILANCE DEPARTMENT -

 If any Adverse Drug reaction occurred during the study, it will be duly noted, and informed to pharmacovigilance cell of Parul Ayurveda Hospital, and treated accordingly or referred to Parul Sevasharam Hospital.

 
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