A Controlled Clinical Study to Evaluate the Efficacy of Dashamoola Ksheera Basti in the Management of Jaanu sandhi Gata vata Vis-A-Vis Osteoarthritis Knee Joint

Introduction:

• Sandhigata Vata is one among Shoola and Shotha Pradhana Vata Vyadhi which is mentioned in the context of Gatavatain classical text. It is characterised by swelling in the joints, and pain which increases on extension and flexion of joints ¹. Osteoarthritis (OA) mentioned in western medicine has similarities with the signs and symptoms of Sandhigata Vata.

• Osteoarthritis is an abnormality of the synovial joints characterised by softening, splitting and fragmentation of articular cartilage not attributable to direct contact with inflammatory tissue. This is usually accompanied by subchondral sclerosis and bony cysts, joint space narrowing and bony outgrowths at tissue joint margins ².

• The prevalence of osteoarthritis among elderly as per the recent study is 56.6%, making it a leading cause of disability. The prevalence of OA rises strikingly with age. It is highly prevalent in those over age of 60. OA accounts for 55% of all arthritis related hospitalisation; 4,09,000 hospitalisation per year for OA as principal diagnosis ³.

• Management in western medicine includes NSAIDs, opioid analgesics and injection gluco-corticoids. Full recovery can be expected only in 85% of adults and role of surgery remains controversial because of poor outcome i.e., inability to recover complete range of motion post-surgery and instability of the joint. Long term usage of above medicines causes gastrointestinal toxicity in 50% of NSAID users, renal and hepatic metabolism impairment and economic burden in case of surgical intervention⁴ .

• In above situation, to explore time hold Ayurvedic therapy is an important area of research. An early effective intervention may not only provide symptomatic relief of pain but also may reduce need for surgical intervention. The treatment modalities described in Ayurveda for Janu Sandhigata Vata include both the Upakrama mentioned in Vata Vyadi and specific modalities mentioned in Janu Sandhigata Vata. Basti chikitsa is one among the most important treatment modality employed in Vata Vyadi.

• Among the different varieties of Basti, Ksheera Basti is considered as having Balakara effect and is indicated in all the Vata Vikara⁵ . It is one formulation which has been evaluated very minimally. Dashamoola Ksheera Paka for Niruha Basti and Siddharthaka Taila⁶ for Anuvasana Basti was used in the clinical trial. The Rasa, Guna, Veerya, Vipaka, and Doshaghnata of individual ingredients and the formulation as a whole was analysed and hypothysed that it is having Brimhana, Rasayana, Vatadoshahara, Balakara, Shothagna, Vedana Sthapaka and Asti Dhatu Poshaka properties which are mainly required in the Samprapti Vighatana of the disease Janu Sandhigata Vata.

• From this perspective the current study was undertaken to evaluate the efficacy of Dashamoola Ksheera Basti in Janu Sandhigata Vata. 

• Mahayogaraja Guggulu⁷ for oral administration and Janu Basti⁸ which is a variety of Swedayukta Snehana was adopted as a control. Ksheerabala Taila⁹ was used for Janu Basti.

Objective of the study:

To evaluate the efficacy of Dashamoola Ksheera Basti (Siddharthaka Taila Anuvasana) in the management of Janu Sandhigata Vata.

Materials & methods:

Source of Data:

Patients were incidentally selected and randomly assigned into 2 groups from the O.P.D and I.P.D of Government Ayurveda Medical College and Hospital, Mysore, India. A total of 116 patients between the age group of 30-70 years fulfilling the criteria for the diagnosis of the disease were registered for the study in prescribed proforma. Out of these, 16 patients dropped out during various stages of the intervention. The study was completed in 100 subjects.

Study Design:

The study was a control with pre and post-test design.

Diagnostic criteria:

• Presence of signs and symptoms of Janu Sandhigata Vata such as Janu Sandhi Shoola, Janu Sandhi Shotha, Janu Sandhi Atopa, Janu Sandhi Stabdhata were considered as diagnostic criteria. Positive Appley's Grind Test, Anterior Drawer sign, Posterior Drawer Sign. Valgus Stress Test, Varus Stress test were taken as objective measures for the diagnosis. X ray anteroposterior view of knee joint was taken for the confirmation of diagnosis. Severity of the Osteoarthritis knee joint was assessed with the help of Kellgren– Lawrence Radiographic Grading Scale of Osteoarthritis.

Inclusion criteria:

• Subjects of all gender belonging to the age group of 30 years to 70 years were selected for the study. Both fresh and treated cases were selected. Subjects with the symptoms of Janu Sandhigata Vata for at least one month of duration were selected.

Exclusion Criteria:

Endocrine disorders, which interfere with the course of intervention were excluded.

Statistical methods:

• The result were analysed statistically by using Descriptive statistics, t test- independent and paired samples, Repeated measure ANOVA and Contingency co-efficient test analysis using Service product for statistical solution (SPSS) for windows software.

Ph y si o l o g i c a l , b i o c h emi c a l a nd radiological investigations done for the study:

• X-ray Antero-posterior view of knee joint was taken for diagnosis of Osteoarthritis. Haematological investigations namely Haemoglobin %, TC, DC, ESR, Random blood sugar, and Urine examinations namely Sugar, Albumin & Microscopic were carried out to rule out other systemic diseases in all the cases. Rheumatoid factor was done whenever necessary.

INTERVENTION:

GROUP A (CONTROL GROUP): A. Mahayogaraja Guggulu in the dosage of 1.5 g per day in three equal divided doses of 500 mg, 2 tablets each of 250 mg in the afternoon and night twice daily with warm water as Anupana for first 8 consecutive days and 2 tablets were prescribed three times daily for following 12 consecutive days. B. JanuBasti with Ksheera Bala Taila of 40 minutes duration for first 8 consecutive days.

GROUP B (TRIAL GROUP): A. The intervention of Group A in the same dosage and pattern.

B. Dashamoola Ksheera Basti with Siddharthaka Taila as Anuvasanain the pattern of Yoga Basti for first 8 consecutive days.

• DURATION: The duration of the study was 20 days.

Assessment criteria:

• Assessment schedule: In the present Clinical trial, three assessments of the subjects were done. Pre-test assessment was done on 0 day i.e., before starting the intervention. Mid-test assessment was done on 8th day i.e., on the day of completion of Basti karma and post-test assessment was done on 20th day i.e., after the completion of intervention.

• Parameters of assessment: Assessment parameters included the clinical grading of signs and symptoms of the disease Janu Sandhigata Vata and WOMAC index for osteoarthritis.

• Assessment was done based on following parameters:

• Sandhi Shotha:

o No swelling :SO

o Mild swelling :S1

o Moderate swelling :S2

o Severe swelling :S3

• Sandhi Shoola:

o No pain :PO

o Mild pain :P1

o Moderate pain :P2

o Severe pain :P3

• Sandhi Atopa:

o No crepitus :A0

o Mild palpable crepitus :A1

o Modertae palpable crepitus :A2

o Audible crepitus :A3

• Sandhi Sthabdhata:

o No stiffness :ST0

o Mild stiffness :ST1

o Moderate stiffness :ST2

o Severe stiffness :ST3

• WOMAC- Index for Osteoarthritis:

• The severity of the Osteoarthritis knee joint was assessed with the help WOMAC score grading given below:

OVERALL ASSESSMENT: The assessment was graded with following manner:

• Marked improvement: 76-100% improvement in signs and symptoms.

• Moderate improvement: 51-75% improvement in signs and symptoms.

• Mild improvement: 26-50% improvement in signs and symptoms

• Insignificant improvement- less than 25% improvement.

OBSERVATION AND RESULTS:

Pre-test observation:

• In this study among 100 subjects, 35 subjects (35.0 %) consulted the hospital for the first time to take treatment and 65 subjects (65%) had already taken different forms of treatment (Allopathic, Unani, Homeopathy and Physiotherapy) of varying duration. In Control Group among 50 subjects pain was severe in 35 subjects (70.0%), moderate in 14 subjects (28.0%) and mild in 1 subject (2.0%). Shotha was severe in 4 subjects (8.0%), moderate in 1 (2.0%), mild in 2 (4.0%) and absent in 43(86%). Crepitus was severe in 28 subjects (56.0%), moderate in 17 (34.0%), mild in 1 (2.0%) and absent in 4 (8.0%).Stiffness was severe in 28 subjects (56.0%), moderate in 17 (34.0%), mild in 1 (2.0%) and absent in 4 (8.0%). In Trial Group among 50 subjects 45 subjects (90.0%) reported severe pain and 5 (10.0%) reported moderate pain. 5 subjects (10.0%) reported severe swelling, 3 (6.0%) reported moderate swelling and 42 (94.0%) reported no swelling.

• Atopa was severe in 32 subjects (64%), moderate in 13 (26%), mild in 1 (2%), and absent in 4 (8%).37 subjects (74.0%) reported severe stiffness, 11 (22.0%) reported moderate stiffness, 0 (0%) reported mild stiffness and 2(4.0%) reported no stiffness. In fresh cases intervention was started from the next day after laboratory investigations and x-ray. In treated cases after complete withdrawal of earlier treatment flush out period of 7 days was given and then intervention was started.

Mid test observation:

• In control group 4 (8.00%) had severe pain, 31 (62.0%) had moderate pain and 15 (30.0%) had mild pain.2 (4.0%) subjects had severe swelling, 3 (6.0%) had moderate swelling, 2 (4.0%) had mild swelling and 43 (86.0%) had no swelling. (14.0%) subjects had severe crepitus, 25 (6.0%) had moderate crepitus, 13 (26.0%) had mild crepitus and 5 (10.0%) had no crepitus. 3 (6.0%) had severe stiffness, 22 (44.0%) had moderate stiffness, 20 (40.0%) had mild stiffness and 5 (10.0%) had no stiffness.

• In trial group 4 (65.00%) had severe pain, 33 (66.0%) had moderate pain and 13 (26.0%) had mild pain. 5 subjects (10.0%) had severe swelling, 3 (6.0%) had moderate swelling and 42 (84.0%) had no swelling. Atopa was severe in 2 subjects (4%), moderate in 30 (60%), mild in 14 (28%) and absent in 4 (8%).4 subjects (8%) had severe stiffness, 29 subjects (54%) had moderate stiffness, 14 subjects (28%) had mild stiffness and 3 subjects (6%) had no stiffness.

Post-test observation:

• In control group (2.0%) had severe pain, 21 (42.0%) had moderate pain, 21 (42.0%) had mild pain and 7 (14.0%) had completely relieved from pain.4 subjects (8.0%) had moderate swelling, 1 (2.0%) had mild swelling and 45 (90.0%) had no swelling.2 subjects (4.0%) had severe crepitus, 14 (28.0%) had moderate crepitus, 25 (50.0%) had mild crepitus and 9 (18.0%) had completely relieved from crepitus.1 subject (2.0%) had severe stiffness, 11 (22.0%) had moderate stiffness, 24 (48.0%) had mild stiffness and 14 (28.0%) had completely relieved from stiffness

• In trial group 3 (6.0%) had severe pain, 1 (2.0%) had moderate pain, 24 (48.0%) had mild pain and 22 subjects (44.0%) had completely relieved from pain. The study showed better result in Trial Group (Group B) than Control Group (Group A) for reduction in pain knee joints with high contingency coefficient value 0.776. )

• 2 subjects (4.0%) had severe swelling, 4 (8.0%) had moderate swelling, 2 (4.0%) had mild swelling and 42 (84.0%) had no swelling. The results obtained regarding the reduction in swelling knee joints showed non-significant result in both the groups with p value 0.400 and 0.458 respectively.

• In post test assessment no subjects had severe atopa, 9 (18%) had moderate atopa, 32 (64%) had mild atopa and 9 (18%) had completely relieved from atopa. The study showed better result in Trial Group (Group B) than Control Group (Group A) for reduction in knee joint crepitus with high contingency coefficient value 0.591.

• 2 subjects (4%) had severe stiffness, 5 subjects (10%) had moderate stiffness, 28 subjects (56%) had mild stiffness, 15 subjects (30%) had no stiffness. The study showed better result in Trial Group (Group B) than Control Group (Group A) for reduction in knee joint stiffness with high contingency coefficient value 0.628.

• In the clinical trial, the result obtained regarding the overall assessment showed better result in Trial Group (Group B) than Control Group (Group A) with high contingency coefficient value 0.581.Assessment of WOMAC score in between the Groups was statistically significant with p value 0.029 (F=3.600), with trial group indicating that Trial Group showed better effect compared to Control Group. For Control Group the decrease was found to be 39.06 (pre: 66.3200; post: 27.2600) and for Trial Group, the decrease was found to be 46.26 (pre: 74.4600; post: 28.3400). Mean difference between the groups was 7.2, which shows Trial Group showed better result than Control Group.

DISCUSSION:

• After observing the overall assessment of the study it revealed that Trial Group (Group B) shows better result than Control Group (Group A) for overall assessment with high contingency coefficient value 0.581.

• Also the result obtained regarding the overall assessment showed clinically and statistically highly significant result in both the groups with p value 0.000.

• This might be because of the Vata Doshahara, Brmhana, Asthi Poshaka and Vedhana Sthapaka property of Dashamoola Ksheera Basti in the management of Janu Sandhigata Vata vis-à-vis Osteoarthritis Knee joint. Though the individual in both the groups have shown clinically and statistically significant improvement in reduction of pain, it was observed that the reduction of pain was faster in Trial group (Group B) when compared to Control group (Group A).

• While most of the patients reported reduction of pain on 5th or 6th day in Trial group. It was on 6th or 7th day in the Control group.

• The recurrence of pain in follow-up done on patients (20 in number) who reported periodically after completion of intervention also suggested that recurrence was relatively high in Control group.

CONCLUSION:

On the basis of concepts, analysis and clinical observations made in this study, the following conclusions were drawn:

• Janu Sandhigata Vata as a clinical condition is similar to Osteoarthritis -knee joint described in western medical science.

• Ksheera basti explained in Charaka Samhita is a formulation advised for Vata Vikara in general. Dashamoola Siddha Ksheera for Niruha Basti and Siddharthaka Taila for Anuvasana Basti was used in the clinical trial. All the formulations were found to be effective in the management of Osteoarthritis knee joint.

• In the study it was observed that trial Group (Group B) showed considerable clinical improvement and statistically highly significant results in reduction of the pain, crepitus, stiffness and WOMAC- index for Osteoarthritis with p value 0.000. It showed non significant result in reduction of swelling with p value 0.400

• Control group (Group A) showed considerable clinical improvement and statistically highly significant result in reduction of pain, crepitus, stiffness and WOMAC-index for Osteoarthritis with p value 0.000. It showed non-significant result in reduction of swelling with p value 0.458.

• On comparing the overall effect of the study, Trial group (Group B) showed considerable clinical improvement and statistically better results than Control group (Group A) with high contingency coefficient value 0.581. In Trial Group it was observed that among 50 subjects 35 subjects (70.0%) reported marked improvement, 12 (24.0%) reported moderate improvement, 3 (6.0%) subjects reported mild improvement and 0 (0.00%) reported insignificant improvement. Whereas in Control Group among 50 subjects there was marked improvement in 17 subjects (34.0%), moderate improvement in 26 (26.0%), mild improvement in 4 (8.0%) and insignificant improvement in 3 subjects (6.0%). Hence, it can be concluded that Dashamoola Ksheera Basti with Siddharthaka Taila Anuvasana has a considerable role in the management of Janu Sandhigata Vata.