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

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 bymustadi 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.