6) Brief Resume of Intended Work:
6.1Need for Study:
Locomotion is one of the important needs of the living beings. Man needs movement to fulfil personal needs and for daily activities. The stress of fulfilling the demand, changed life style, bad postures, excessive traveling with jerky movements etc. in turn produce stress on the Spinal cord. Likewise progressive disorders affecting Pelvis, structural changes, contribute to the condition. The end result may be one of the important syndromes which effects the locomotion. So Sciatica is one of the syndrome that which affects the locomotion.
In Ayurveda, Gridrasi is counted under 80 types of Nanatmaja Vatavyadhi. It affects the locomotion of the person leading to difficulty in walking.Person affected with the disease walks like “Gridhra”or Vulture hence it is named as Gridrasi. Acharya Charaka has mentioned that, in Gridhrasi, pain starts from Sphik and radiates downwards to Kati, Prishta, Jangha, Uru and Pada and there will be Toda (pricking sensation), Stambha (stiffness) and Mruhuspandana (twitching) inwaist, hip, back of the thigh, knee, calf and foot respectively, found in Vataja type and Tandra, Gaurava and Arochaka in addition for Vata Kaphaja type.
This disease is having a incidence ratio 13-40% of the general population with a life time incidence.
In Modern literature it can be correlated with the disease Sciatica because in Sciatica, pain is found along the course of Sciatic Nerve, that is to say in the buttock, back of the thigh, outside and back ofthe leg and outer border of the foot.Sciaticais generally caused by the compression of Lumbar nerves L3, L4, or L5, or sacral nerves S1, S2 or S3 or by the compression of Sciatica nerve itself.This can also occur due to Lumbar disc prolapse or any injury to the vertebral column.
Surgical Innervations, Non-steroidal anti-inflammatory drugs, Analgesic pills and ointments are popular remedies for Sciatica which often decrease Low-backache and improve mobility. But these are all symptomatic treatments and have their own side effects. Surgical correction may lead to other complications and is uneconomical. The pain killers and other medicines cannot be used for long term as it may lead to gastric irritations. Hence there is a need for study on Sciatica,to find an effective, affordable, easily available and economical method to treat cases of Sciatica through Ayurveda.
Basti is one of the important treatment principles for Gridrasi. It alleviates Vata, reduces the pain and does the Shodhana and Shamana of the body.
Erandamooladi Niruha Basti is Deepaniya and Lekhaniya and it is best mentioned in Gridrasi Chikitsa as it alleviates Vata and reduces pain in Kati, Prishta, Jangha, Uru and Pada. So it is selected for the study in one group and Shampakadi Niruha Bastiis taken for study in second group as it alleviates Vata and it reduces pain in Prshta, Uru and Trika region. Sahacharadi Taila is selected for Anuvasana Basti which is mentioned in Vatavyadhi Chikitsa for Pavanapeeditha Deha Gati.
The intended work here is an attempt will be made to bring out efficacious economic and affordable formula in the management of Gridrasi. Here 40 patients will be taken in 2 groups with each group 20 patients. Group-A will receive Vatari Guggulu and Erandamooladi Niruha Basti. Group- B will receive Shampakadi Niruha Basti and Vatari Guggulu.
6.2Review of Literature
1.Explanation of Gridrasi.1,2,3
2.Explanation of Sciatica.4,5,6
3.Explanation of Vatari Guggulu.7
4. Explanation of Panchakola churna.8
5. Explantion of Kala Basti.9
6. Explanation of Sahacharadi Taila.10
7. Explantion of Erandamooladi Niruha Basti11
8. Explanation of Shampakadi Niruha Basti.12
Previous Research Works Done:
· A Comparative study on the role of Yoga Basti& Agni karma in the management of Gridhrasi by Dr. Lohith. B.A, S.D.M.College of Ayurveda, Hassan, 2006.
· A Critical Study of Kati Basthi in Gridrasi by Dr. Ramachandra,S.D.M. college of Ayurveda, Udupi, 2004.
· To Evaluate the effect of Vishamushtivati and MatraBasti in the management of Gridhrasi(A Comparative Study) by Dr. Dhananjay. K, Government Ayurvedic Medical College, Mysore, 2002.
· Padmavati Venkatesh – A clinical study on Gridhrasi with special reference to its management through Niruhabasti and Trayodasanga Guggulu – A.M.V. Hubli – RGUHS 2000
· Tripati J.K. – Gridharasi Mein Basti Chikitsa Ka Prayogik Adhyayan. In 1985 Govt. Ayurvedic College, Pandit Ravishankar University, Raipur.
· Kazi Mohammed – Role of Swedana in Gridhrasi. In 1984 at Kerala Ayurveda University, Thiruvananthapuram
· Pavan Kumar – Concept of Gridhrasi in Ayurveda and Modern Medical Sciences and Its management by An Ayurvedic drug Rasona (Allium sativum). In 1993 at B.H.U.Varanasi
6.3 Objectives of Study:
1 To understand Gridrasi according to Ayurvedic literature and Sciatica according to Modern literature.
2 To see the efficacy of Erandamooladi Niruha Basti along with Vatari Guggulu in the management of Gridrasi.
3 To see the efficacy of Shampakadi Niruha Basti along with Vatari Guggulu in the management of Gridrasi.
7)MATERIALS AND METHODS:
The present clinical study entitled “A COMPARATIVE CLINICAL MANGEMENT OF GRIDRASI(SCIATICA) THROUGH BASTI AND VATARI GUGGULU” is a clinical trial to assess efficacy of Erandamooladi Niruha Basti and Shampakadi Niruha Basti along with Vatari Guggulu.
7.1 Source of Data
Ø Minimum of 40 patients suffering from Gridrasi will be taken for the study from OPD and IPD of Ayurveda Mahavidyalya, Hubli.
7.2 Methods of Collection of Data
a. A clinical survey of subjects attending the OPD and IPD of Post Graduate Department of Kayachikitsa, Ayurveda Mahavidyalaya Hospital, Hubli will be made and subjects fulfilling the criteria of diagnosis as per the Proforma will be selected for the study.
b. A clinical evaluation of patients will be done by collection of data through information obtained by history, physical examination, laboratory tests and Radiological analysis with X-ray.
c. Review of literature will be done from Post Graduate Library, Department of Kayachikitsa, Ayurveda Mahavidyalaya, Hubli, and from Authentic Research Journals, Websites and Digital Publications etc.
d. The drugs required for the clinical study will be procured and prepared in the department of Rasa Shastra and Bhaishajya Kalpana, Ayurveda Mahavidyalaya, Hubli.
Diagnostic criteria
1. Pain starting from low back and radiating down to back of thigh, knee, leg and foot all along the course and distribution of Sciatic nerve.
2. SLR test positive.
3. Lasegue’s sign positive.
Inclusion Criteria
1. Patient having clinical features of Gridrasi/ Sciatica.
2. Patients of either sex and age between 20-60 years.
3. Subjects with or without disc lesions.
Exclusion Criteria
1 Traumatic cases and Tuberculosis of Spine.
2 Age group below 20 year and above 60 years.
3 Subjects with Infective,Neoplastic conditions of Spine and Metabolic disorders.
4 Pregnant and lactating women.
Parameters of study
· Subjective Parameters :
1 Ruk
2 Sthamba
3 Toda
4 Spandana
5 Tandra
6 Aruchi
7 Gourava
· Objective Parameters
1. SLR test positive.
2. Lasegue’s sign positive.
3. LS-Spine x-ray.
Study Design: A comparative clinical study
Sample size: Minimum of 40 subjects diagnosed with Sciatica (Gridrasi) will be selected incidentally and randomly categorized into two groups each containing 20subjects.
PLAN OF TREATMENT:
Group - A:
· Amapachana with Panchakola Choorna.
· 5gm twice daily with ushnoadaka before food till Nirama lakshana seen.
· Erandamooladi Niruha Basti in Kala Basti schedule.
· Vatari Guggulu for Shamana 500 mg BID with ushnodaka for 30 days.
· Pathya ahara and Pathya vihara will be advised to all the subjects.
Group - B:
· Amapachana with Panchakola choorna.
· 5gm twice daily with Ushnodaka before food till Nirama lakshana seen.
· Shampakadi Niruha Basti in Kala Basti schedule.
· Vatari Guggulu for shamana 500 mg BID with Ushnodaka for 30 days.
· Pathya ahara and Pathya vihara will be advised to all the subjects,
Total Duration: 2 month
Follow up Study: 2 month
Assessment Criteria
The data, which are obtained by the clinical trial, will be statistically analyzed by required stastical test.
Change in clinical features of Gridrasi before and after the treatment based on improvement in Scoring Index. The result will be recorded as;
Marked relief - Above 75% improvement
Moderate relief - 50% - 75% improvement
Mild relief - 25% - 50% Improvement
No relief - Below 25% improvement
7.3 Does the study requires any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.
YES
The study will be a human clinical study no animal experiments will be conducted.
Investigations:
Blood Routine
Urine Routine
RBS
X ray Lumbo-Sacral spine AP & Lateral view.
MRI (if necessary)
Interventions:
Group A
· Amapachana with Panchakola Choorna5gm BID with ushnoadaka before food till Nirama lakshana seen.
· Basti karma
Poorvakarma:
1. Sthanika Abhyanga with Moorchita Tila Taila over Udara, Shroni, and Nitamba Pradesha will be done.
2. Bashpasweda will be given.
Pradhanakarma:
NiruhaBasti in Kalabasti schedule.
NiruhaBasti- Erandamoooladi Niruha Basti .
Snehabasti- Sahacharadi taila.
Paschat karma:
After the administration of Snehabasti, and after the catheter is removed Tadana (strokes) done on Nitamba Pradesha .Then patient is made to lie down in supine position, then rub soles of the patient,and ask the patient to flex his legs.at the hip and knee for several times.
· Shamanoushadhi
Vatari Guggulu 500 mg BID along with ushnodaka as Anupana, for 30 days.
Group B
· Amapachana with Panchakola choorna. 5gm BID with ushnoadaka before food till Niramalakshana seen.
· Basti karma
Poorvakarma :
1. Sthanika Abhyanga with Moorchita Tila Taila over Udara, Shroni and Nitamba Pradesha will be done.
2. Bashpa Sweda will be given.
Pradhanakarma:
Niruha Basti in Kalabasti schedule.
Niruha Basti- Shampakadi Niruha Basti.
Sneha basti- Sahacharadi taila.
Paschat karma:
After the administration of Snehabasti ,and after the catheter is removed Tadana(strokes) done on Nitamba pradesha .Then patient is made to lie down in supine position, then rub soles of the patient, and ask the patient to flex his legs, at the hip and knee for several times.
· Shamanoushadi
Vatari Guggulu500 mg BID along with Ushnodaka, for 30 days.
7.4 Has ethical clearance been obtained from your institution?
YES
Ethical clearance has been obtained by the ethical committee constituted by Ayurveda Maha Vidyalaya, Hubli, and written consent will be taken by each individual patient or by an attendant if the patient is illiterate, on a printed consent form.
8).LIST OF REFERENCES:
1 Prof. K.R. Srikantamurthy, Ashtanga Hridyam, Pageno-544,ChowkhambaKrishnadas Academy, Varanasi ,edition 2007.
2 KavirajAmbikaduttashastri,SushrutasamhitaAyurvedatattvasandipikaHindicommentary,Pageno-234,ChowkhmabaSanskritsamsathan,Varanasi,14th edition 2003
3 Dr.BrahmanandTripati,Charakasamhita,Charakachandrika,Pageno-947,Hindi commentary,Chowkhmaba surbhaati prakshaan,Varanasi.edition2005
4 Dr.SomenDas,Concise Text Book of Surgery,Page no-404,Kolkata 6th edition 2010.
5 Nicholas A.BoonDavidson’s Principles and Practice of Medicine Pg No-1242, edited by 26th chapter, ,20th edition2006
6 Swash Micheal, Hutchinson’s clinical methods, ELBS publications London, Page 252, 1995,20thedition
7 Kaviraj Ambikadattashastri, Bhaishajya Ratnavali of ShriGovindadasji,Page no-155,Chowkhmaba Sanskrit bhavan,Varanasi,first edition 2006.
8 Dr. Indra Tripathi Yogaratnakara, commentary ,Pageno89 Krishna Das Academy, , Varanasi,1st edition,1998.
9 Prof. K.R. Srikanthamurthy, Vagbhata’s Astanga Hridaya Page 510 Krishnadas Academy, Varanasi, 4th edition, , 2000.
10 P.V.Sharma ,Agnivesha’s Charakasamhita Page no 594,Choukhambha publications, Varanasi, 6th edition, , 2001.
11 Prof.K.R.Srikanthamurthy, KrishnadasVagbhata’s Astanga Hridaya Page 560 , Academy, Varanasi, 4th edition, 2000.
12 Priyavatsharma Susrutasamhita Dalhanas commentary, English translation Page no-644,choukhmabavishwa bharati,Varanasi.edition,2010.