Evaluation of the combined efficacy of Ruksha Churna Pinda Sweda ,Virechana and Kshara Basti(Yoga Basti)in the management of Amavata(Ankylosing Spondylitis):Single Arm Open Ended Clinical Study

RESEARCH QUESTION

What is the combined effect of Ruksha churna pinda sweda, Virechana and Kshara basti(*Yoga  basti )*followed by Trayodashanga guggulu and  Rasnasaptak kwatha in the management  of Amavata (Ankylosing spondylitis).

HYPOTHESIS

Null hypothesis:(H0)

There is no significant effect of Ruksha churna pinda sveda, Virechana and Kshara basti(Yoga  basti) followed by Trayodashang guggulu and Rasnasaptak kwatha in the management  of Amavata ( Ankylosing spondylitis).

Alternate hypothesis:(H1)

There is significant effect of Ruksha churna pinda sveda, Virechana and kshara basti( Yoga basti ) followed by Trayodashang guggulu and Rasnasaptak kwatha in the management of  Amavata ( Ankylosing  spondylitis).

NEED OF THE STUDY

·       The prevalence of AS is generally believed to be between 0.1% and 0.4% globally  while in India, around 0.25% population is estimated to be affected4. The disease is more  often manifest in young males than in females with the ratio approximately 3:15.

·       Ankylosing spondylitis is a chronic inflammatory condition marked by the formation of new bone in the axial skeleton. It leads to ongoing and irreversible structural deterioration of the spine, sacroiliac, and peripheral joints. Additionally, it may present with extra-articular symptoms like uveitis, psoriasis, inflammatory bowel disease, and cardiovascular and pulmonary abnormalities.

·       The initial treatment approach for ankylosing spondylitis typically involves nonsteroidal anti-inflammatory drugs (NSAIDs) and disease-modifying antirheumatic drugs (DMARDs). However, these medications often fall short in effectively managing disease symptoms. Biologic therapies, specifically anti-tumor necrosis factor (anti-TNF) agents, are currently approved for AS treatment and have demonstrated efficacy in achieving clinical remission for durations extending up to 8 years.

·       Unfortunately,there are some adverse effects associated with these drugs which can be considered mild or severe and these treatments are expensive and prognosis is very poor.

·       Unavailability of satisfactory treatment in bio-medicine leads to permanent deformity in Ankylosing spondylitis. There is a need to search satisfactory treatment available in other medical system. Hence there is a  need of cost effective treatment,which improve the Quality of Life in patients having no side effects.

·       The menifestation of Vata Vyadhi, a condition attributed to Vata dosha imbalance, becomes evident in fully developed ankylosing spondylitis (AS). As the disease advances, nearby articular or joint tissues undergo destruction, with original cartilage being replaced by bone through fusion. Consequently, joint bones fuse together, resulting in stiffness and reduced mobility. This fusion process ultimately leads to the characteristic "bamboo spine" formation, a hallmark of AS.

·        In Ayurveda ,Ankylosing spondylitis is not mentioned as a separate disease  in clasical texts, but considering the symptom and the cause, disease can be  approached with the concepts of vatavyadhi with special reference to Amavata.

·        The  main symptoms are shoola, graha that mainly occurs in kati,trika and prishtha desha which is  a dominant features of vata dosha.

·       Stambha /graha is could be seen when kaphavritt/amavritta vata prokopa develops6.

·       Pinda Sveda is describe in samhita in the context of svedana to allivate vata and kapha  dosha and ruksha churna pinda sveda  having the quality of ruksha guna with vatahara dravya  which is useful in kaphavritta vata7.

·       Deepan – Panchakola have Laghu, Ruksha ,and Sukshma Guna ,Ushna Virya,Katu Rasa,Katu vipaka and kaphahara and pachana properties . BY Katu Rasa and Vipaka Panchakola helpful in Agnideepana.

·       Virechana is a therapy which is indicated for Shodhana purpose. By virtue of it, the Doshas are eliminated by Adhomarga. After niram condition of *vata ,*the treatment of nirama vata should be snehana ,svedana and snigdha virechana.

·       Basti is considered as Ardhachikitsa and best measure to control vitiated Vata Dosha. Basti helps in the management of Amavata as Vata is  of the main causative factors.

·       Basti is very useful in chronic stage of Amavata.Both Anuvasana and Asthapana Basti are recommended in Amavata. Chakradutta has recommended Saindhavadi Taila Anuvasana Basti and Kshara Basti as Asthapana Basti in Amavata.

OBJECTIVES OF THE RESEARCH PROJECT

 PRIMARY:         To evaluate the combined effect of Ruksha churna pinda sweda, Virechana and Kshara basti(yoga Basti) followed by Trayodashang guggulu  andRasnasaptak kwatha in  the  management of reducing pain  and stiffness in the Amavata. (Ankylosing spondylitis).

SECONDARY: 1) To reduce the other symptoms like inflammation, fatigue etc.

2. To improve the Quality of Life in patients of Ankylosing spondylitis.

3)To asses the inflammatory markers changes- qCRP,ESR,Interleukin-17

MATERIALS AND METHOD

STUDY TYPE: Interventional

STUDY  DESIGN: Single arm open ended  clinical study

SAMPLING METHOD: Non Randomisation

GROUPING: Single Arm

TIMING: Prospective

**MASKING:**open Label

ENDPOINT:Efficacy

SAMPLE SIZE- 27

SAMPLE SIZE CALCULATION

A study on Ankylosing spondylitis is proposed to evaluate the impact of What is the  combined effect of Ruksha churna pinda sweda, Virechana and Kshara basti(Yoga  basti) followed by Trayodashanga guggulu and Rasnasaptak kwatha in the management  of Amavata (Ankylosing spondylitis) on pain management beside other indicators.

 A study done earlier suggest the mean is scored among such patients is around 6 with standard deviation of 2.

It may be assumed that VAS SCORE may be further reduce by 20 % from a mean level of 6 to 4.8% after the intervention.

 In sample size calculation following parameter are used-

Level of significance is 5% and power of the test is 80% two sided test and effect size of 0.60% gives a calculated sample size of 24.

Adjusting this for10% drop out study would include 27 patients.

CRITERIA FOR SELECTION

Patients are collected from OPD (AIIA) in the basis of Ankylosing diagnostic criteria.

INCLUSION CRITERIA

EXCLUSION CRITERIA

|1. Age between 18 yrs. to 60 yrs.

1. Chronicity of more than 5 yrs.

|2. Chronicity: 1yr to 5 years.

2. Severely deformed joints.

|3. Gender: Both

3. Cardiac disease, pulmonary tuberculosis, severe lung disease, diabetes and pregnant women.

|4. . Diagnosed cases of Ankylosing

Spondylitis.(upto Grade 2 of sacroiliitis)

4. Patients unfit for Snehana, Svedana,  Virechana and Basti Karma*.*

|5. Socio- economic status: All

CRITERIA  FOR  DIAGNOSIS : The Assessment of Spondylo Arthritis international Society (ASAS) criteria for Ankylosing Spondylitis11.

(ICD-11 code-FA92.0 axial spondyloarthrits)

ASAS classification criteria for axial Spondylo Arthritis are as follows-

•        Back pain for 3 months or longer

•        Age at onset < 45 years

•        Sacroillitis on imaging (radiographs or MRI) plus one or more Spondylo Arthritis features

•        HLA-B27 plus two or more other Spondylo Arthritis features

 Spondylo Arthritis features are as follows:

•        Inflammatory back pain

•        Arthritis

•        Enthesitis

•        Uveitis

•        Dactylitis

•        Psoriasis

•        Crohn disease

•        Good response to NSAIDs

•        Family history of SpA

•        HLA-B27s

•        Elevated ESR

Total no. of. Days treatment given

•       Ruksha churna pinda sveda with Kolakullathadi choorna for 7 days.

•       Snehapana with Shatpala ghrita for (3-7 days)(until samyak snigdha lakshana obtained**)** an average of 5 days.

•       Sarvanga abhbyanga with Saindhavadi taila and swedana with dashamoola kwatha for 3 days.

•       Virechana karma with Trivrit avaleha,Triphala kwatha and Gandharvahastadi eranda taila  for 1 day.

•       Samsarjana krama with peya, vilepi etc. for (3-7 days) an average of 5days as per shuddhi.

•       Yoga basti for 8 days :

Anuvasan vasti with Br.Saindhavadi taila and Shatapushpa for 5 days (on 1,3,5,7,8th day)

Niruha basti with Guda, Saindhav Lavana, Amlika, Shatpushpa kalka and Gomutra arka for 3 days (on 2,4,6th day)

•       So total no of days with an average of( Rukshana , Snehana ,Virechana and

Samsarjana krama and Yoga basti is 30 days) + (oral medication -30days) +( follow up after completion of shamana aushadhi– 30days ) = 90days

TOTAL STUDY DURATION-90 DAYS

 ASSESSMENT PARAMETERS 12

1.     BASDAI (Bath Ankylosing Spondylitis Disease Activity Score)

2.     BASFI (Bath Ankylosing Spondylitis Functional Index)

3.     BASMI (Bath Ankylosing Spondylitis Metrology Index)

4.     Visual Analogue Score

5.     C-Reactive Protein (q-CRP)

6.     ESR

7.     Serum Interleukin 17- As per feasibility.