Comparative Clinical Trial on Aragwadha Erand and Trivrutta Eranda Nitya Virechana in Gridhrasi (Lumbago Sciatica Syndrome): A Study Protocol

Background: At present, the life style is gradually shifting away from healthy living, and therefore people fall victim of various diseases. Sedentary lifestyle, stress, improper posture, continuous jerky movements, long travelling, etc., put maximum pressure on the spine and lower portion of the pelvis. About 80–90% of people get affected by low back pain and 5% of those become victims of sciatica. Aim: Studying the effect of Trivrut Eranda Tailam and Aragvadha Eranda Tailam Virechana in Gridhrasi (Lumbago sciatica syndrome). Objectives: To study the effect of Trivrut Eranda Tailam in Gridhrasi, To study the effect of Aragvadha Eranda Tailam in Gridhrasi and to compare the effect of Trivrutta Eranda Tailam and Aragavadha Eranda Tailam in Gridhrasi. Methodology: This study will be a Randomized controlled interventional trial to be conducted on 30 participants. The participants will be divided into two groups viz. Group A and Group B. The Study Protocol Parwe et al.; JPRI, 33(39A): 68-74, 2021; Article no.JPRI.71202 69 patient in Group A will be given Trivrutt Eranda Tailam (15 patients) and Group B will be given Aragvadha Eranda Tailam (15 patients). Results: Nitya virechan will be carried out in both these groups. The results will be compared on the basis of SLR test [Straight leg raising test], Lassegue sign, Flip test, Bowstring test and Serum electrolytes used for Gridhrasi. Conclusion: Conclusions will be drawn on the result.


INTRODUCTION
At present, the life style is gradually shifting away from healthy living, and therefore people fall victim of various diseases. Sedentary lifestyle, stress, improper posture, continuous jerky movements, long travelling, etc., put maximum pressure on the spine and lower portion of the pelvis. About 80-90% of people get affected by low back pain and 5% of those become victims of sciatica [1]. Low back pain is not a onetime phenomenon; rather it is characterized by the commonest presenting symptom is low back pain with or without the pain radiating down the back of the leg (sciatica) [2]. Sciatica is a crippling disease cause pain in hip and to the whole path of sciatic nerve; it referred down back of the leg and sometimes to the foot. Sciatica is a clinical condition characterized by severe pain started from the low back region and radiating down along the course of the leg. This is common entity encountered in clinical practice [3] [4].
[7]. Another classical clinical investigation is Sakthiutkshepa Nigraha(restricted movement of lifting of the leg) told by Sushruta [8]. Vata caused rigidity, pain and pinning sensation which affect, first, the buttocks and then descends to low-back, knee, calves and legs gradually, repeated pulsation in limbs also symptoms like drowsiness, heaviness and anorexia [9]. Back pain is second only to the common cold as the most frequent reason for visiting a physician and is the most common chronic pain syndrome in industrial countries. It is mostly a self-limited illness. Low back pain accounts for 30-50% of rheumatic complaints encountered by general practitioners. The incidence in the industrial sector in India is 11% in textile workers. The highest prevalence is in persons aged 45 to 65 years. Low back pain becomes chronic only in 3-5% of cases. Radicular pain is one among the most common clinical manifestations of back pain [10]. The disease affects daily, routine activity of victim's life as it restricts the leg movement. Shooting pain occurs from buttock and goes down up to a foot. Victim is having pricking pain (Toda), twitching or trembling sensation (Spandana) due to stretching of sciatic nerve and paresthesia (Supti). Clinical diagnosis is based on history with straight leg raising (SLR) test (Sakthikshepa Nigraha). Diagnosis conformation is done through X-ray and Magnetic Resonance Imaging (MRI). The treatment of the sciatica is done commonly with analgesics to relieve pain and physiotherapy for regulating the spinal compression. That will help to certain extent but it is not of ultimate cure [11].Surgeries for this condition is moreover expensive and there are chances of recurrence as well [ [13]. Nitya virechana is advised in the line of treatment of Jalodara, Kushta, Gridhrasi, Katishool etc. Nitya Virechana is feasible as well as can be easily given without hospitalization in alpa bala patients also [14]. Hence we planed nitya virechana for Gridhrasi.

BACKGROUND
In Vatavyadhi mrudu virechana mentioned with Tilvak Ghrita, Saatala Ghrita, Eranda Tailam, etc., with milk. As by the above references defected vata is the main causative factor for Gridhrasi for that planning treatment with Sneha Virechana by the Trivrutta Eranda Tailam and Aragvadha Eranda Tailam. And Nitya virechan (daily purgation) is a type of virechana (purgation therapy). Whenever there is a large number of toxins present in the body, we have to remove it in small quantities daily [15] [16]. Preferred drug to treat Vata because most of the properties of common Eranda drug and respected other drug is opposite to Vata. It's hot, unctuous, heavy and laxative properties helps to pacifies Pakvshaysthavata, Anulomak, Virechaka in nature cure constipation by dislodging the encrusted matter. The preparation contains two more ingredients side by side with which it become more potent to pacifying Vatadosha. The medicine is administered internally in the dosage of 10ml with luke warm water. It's an effective medicine for Gridhrasi.

Exclusion Criteria
1. Age below 20 years and above 60 years 2. Any lesion of sciatic nerve (ICD-10 criteria G57.0) 3. Any lesion of due to inter-vertebral disc disorder (ICD-10 criteria M51.1) Interventions: Total duration of intervention will be the same for both groups and fallow up will be on 15 days in both groups. Table 1.
Criteria for discontinuing or modifying allocated interventions: If the symptoms get aggravated during treatment such subject will be withdrawn from study and treated free of cost till becomes alright.

Follow Up: 15 days
Statistical analysis: The progressions from pattern will be dissected by utilizing Paired and Unpaired't' Test for target standards. For objective criteria unpaired t-test will be applied.
For subjective criteria Chi-square test will be applied. Others tests will also be applied if required. Suitable change can be made if required during course of study for better.

EXPECTED RESULTS
Primary outcome: We will see the impact of nitya virechana on subjective parameters during treatment. Information will be communicated as a standard mistake of mean at 5 % Level of confidence. It is hypothized that Trivrutta Eranda Tailam and Aragwadha Eranda Tailam nitya virechan will be more effective in subjective with no any adverse effect.

DISCUSSION
In the Human body lumbar spine is the pillar of all the muscles and nerves tree. In that any kind of structural deformity makes a trouble for human being. And worldwide also it is the site of most of costly orthopedic difficulty for the world"s developing countries rather than developed country, as well as industrialized countries. It is site of miracles well said. The nervous system with that the autonomic nervous system works side by side under the lumbar spine area so it is very difficult to treat as well as very carefully to handle such situation. With the heavy schedule busy, professional and social life having usual sitting posture in the office, in the industrial area work did their continuous work with same posture of back and leads to overexertion, jerk on back .that exerts a pressure on vertebral column leads to get injury to the spine as well nerve compression too. And reflects the tremendous to the back and with compression developing the radiating pain to lower limbs either side. In Gridharsi there is pain which goes throughout lower back region and radiates to lower limbs, that gets stiffness, restricted movements, numbness, and tingling sensation in the leg. Degenerative disc disease may irritate the nerve root and cause sciatica, as can mechanical compression of the sciatic nerve, such as from spondylolisthesis, spinal stenosis or arthritis in the spine [20][21][22][23][24][25][26]. Strength: If proposed study will results in the positive outcome then it will be established new mode of management for the Gridhrasi. In society, we will be provided economical and effective hypoglycemic management for Madhumeha.

CONCLUSION
Conclusion will be mentioned after the analyzing data.

LIMITATIONS
Will be convincing the patients for nitya virechan for 15 days and for hospitalization.

CONSENT
The made consent will be taken from the patient before starting the assessment. During the investigation the classification of every patient will be kept up. With all the data model assent structure and other related documentation will be given to members.
Dissemination policy: The information will be dispersed by paper distribution. Creation qualification rules and any proposed utilization of expert scholars.