6. BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY:
Movement is the vital sign of active life. In Sandhigata vata the movement is restricted due to pain and inflammation in the joints these restricted movements cause a lot of hard ships in the present competitive world.
Sandhigata vata is the most common form of joint disorders among the elderly and obese persons and many working days are lost it is major cause of morbidity and chronic disability as well as burden on health care resources it is a chronic degenerative disorder of multifactorial etiology
Sandhigata vata can be compared with osteoarthritis of contemporary medical science osteoarthritis is the second largest muscular skeletal disorder in the world population 30% after back pain 50% the reported prevalence of osteoarthritis from a study in rural india is5.78% among 80% of world population the prevalence is usually seen in the age group of 60-65 years with some neurological evidences only 20-30 of osteoarthritis are associated with symptoms1
Acharya charaka2 has described the disease separately by name sandhigata anila under chapter Vata vyadhi. He defined it as disease with symptoms of sotha (swelling) which is palpable as (air filled bag) vatapurnadruthi sparsha and pain on flexion and extension of joints (akunchana prasarana vedana). Susrutha3 described pain, shotha (swelling) and diminishing of movement at the joints involved (hanta sandhi gata) as the symptoms of sandhigatavata. According to Vagbhata features are vata poorna druthisopha and akunchana prasarana janya vedana. For such a grave and most prevalent condition unfortunately there is no adequate and satisfactory treatment in contemporary medicine. Mainly analgesics and anti inflammatory drugs are used, to offer some symptomatic relief. In rare conditions surgery is also undertaken without much benefit further these measures cause a lot of side effects in long run. Hence a disease modifying drugs and procedures are the need of the day.
Ayurveda offers many solutions for this condition without causing any unpleasant/ adverse effects. Therefore a classical yoga from Gadanigraha know as Guggulu vatakam has been selected for proposed clinical study along with Ksheera-bala taila matra basti in one group and without matra basti in another group.
HYPOTHESIS:
1.GUGGULU VATAKAM4:
The ingredients are guggulu, dasamoola, triphala, pippali, twak, ela. Guggulu is well known for Vata vyadhi in Ayurveda especially joint disorders. It is a well-known vedana sthapana drug further it is also a rasayana (new guggulu) and dasa moola kwatha with which bhavana is undertaken is also having same properties with sothagna (antiinflamatory) action. Hence the combination of both these two drugs are likely to be effective in sandhigata vata where in ruja (pain) sotha, and restricted movements are the main symptoms. Further pippali and triphala are likely to enhance the analgesic and anti inflammatory action of guggulu vatakam hence it has been selected.
2. KSHEERA-BALA TAILA MATRA VASTI5:
Matravasti with ksheera-bala tailam is selected in one group along with Guggulu vatakam because vasti is the prescribed line of treatment for Vata vyadhi especially in sandhigata vata as the pathology lies in the sandi, Asthi, majja sthana.
Ksheera bala contains bala moola, Go-ksheera which are well known rasayanas and vata hara dravyas hence it is selected for this clinical study.
6.2 REVIEW OF LITERATURE:
Sandi’s and the diseases affecting them were well known from the Vedic period. One can observe description of body parts in Atharvanaveda where in the words “Januni and Ashtivantau”6 were used to denote knee joints. The disease Sandhigatavata had not been mentioned as such in Vedic literature.
Charakaacharya7-mentioned about sandhigata Vata as sandhigatoanila. Sushruta samita refers this in vatavyadhi Nidana8. Astanga samgrahakara and hridayakara also stated the same as Charaka and Sushruta9. Sandhigata vata has been explained in Harita samhita10. Madhav Nidana has explained about the sandhigata vata under Vata vyadhi chapter11.
Yogaratnakar, gadanigraha; vangasena also explained Sandhigatavata.
Sandhigatavata can be correlated with osteoarthritis of modern science, due to the nature of disease and its similarity of cardinal symptoms.
Acharyas have explained the treatment procedures like Abhyanga, Anuvasana vasti, Upanaha, Bandhana, Unmardhana etc for Vatavyadhis, which holds good in the context of Sandhigatavata also. Gadanighraha while explaining the chikitsa of sandhigata vata described Guggulu vatakam. Matra vasti is especially indicated in sahasra yogam.
Previous researches undergone on the same disease:
a)Shah Piyush: A Comparative Study of Rasnadi Ghana vati with or without Abhyanga and Sweda in the management of Sandhigatavata; Dept of Kayachikitsa, Govt. Akhandanand Ayurvedic College; Gujarat Ayurveda University Jamnagar,2003
b) Singh D K: A Clinical Study of snehana, Swedana and Rasnadi guggulu in the management of Sandhigatavata, Dept. of Kayachikitsa, National Institute of Ayurveda, Rajasthan University, Jaipur, 2002
c) Khuge S L: A Clinical Study on the effect of some Rasayana drugs along with Abhyanga and Swedana w.s.r.t Sandhigatavata; Dept of kaya chikitsa, Govt. Ayurvedic college.
d) Shakuntala Tottar : Evaluation of efficacy of Ajmodadi Vati in Sandhigata vata (osteo-arthritis), Dept. of Kayachikitsa, D.G.M.Ayurvedic Medical College, Gadag.
e)Syal Kumar A.J: Evaluation of Rasna panchaka Guggulu in Sandhigata vata (osteo-arthritis), Dept. of Kayachikitsa, D.G.M.Ayurvedic Medical College, Gadag.
f) Pai Surekha: A controlled Clinical Study on the effect of Panchatikta Guggulu Ghrita Anuvasana Basti in Janu Sandhigata Vata w.s.r.to Osteo-arthritis, Dept. of Kayachikitsa,S.D.M.College of Ayurveda Udupi.
6.3. AIMS AND OBJECTIVE:
1. Assessing the clinical effect of guggulu vatakam in Sandhigatavata. OA (singularly)
2. Assessing the clinical effect of guggulu vatakam and ksheera bala taila matra vasti (combinedly)
3. To study the disease sandhigata vata in detail.
7.1 Source of Data:
a. Subject: Patient suffering from signs and symptoms of Sandhigatavata will be selected from OPD & IPD of D.G.M.A.M.C & Hospital and medical camps conducted by the college after duly following the inclusion and exclusion criteria.
b. Literary: Required literary information for the intended study will be collected from Ayurvedic, Modern, textbooks and Internet and updated with recent journals of modern medicine and ayurveda.
c. Preparation of Drugs:
1. Guggulu vatakam will be prepared in the baisajya kalpana department of D.G.M.A.M.C & Hospital.
2. Ksheera bala taila for matra vasti will also be prepared in D.G.M.A.M.C & Hospital pharmacy.
d. Composition of medicine:
1.Guggulu Vatakam (Gada Nigraha)
S.N. / DRUGS / RASA , GUNA, VIRYA, VIPAKA / KARMA / QUANTITY1 / Gugglu / Katu tikta rasa, laghu ruksha guna, veerya usna, katu vipaka / Tridosha shamaka, rasayana, vrysa. rasayana, / 5 Pala
2 / Triphala / Pancha rasa, expect lavana,laghu ruksh guna, ushna sheeta veereya, madhura vipaka / Tridosha shamaka , rasayana,
Anulomana , Vrysa / 3Pala
3 / Pippali / Katu rasa, Laghu snigdha guna, Ushna veerya, Madhura Vipaka / Vata kapha shamaka , Rasyana, vrysa / 1 Pala
4 / Twaka / Katu, madhura rasa, usna virya, katuvipaka ,lahu guru guna. / Sukrala, varnya. / 2 Tola
5 / Ela / Katu, madhura rasa , sheeta virya, laghu ruksha guna, Katu vipaka / Kapha vaata shamaka, hrdya, deepana / 2 Tola
6 / Dashmoola / Katu tikta madhura kasayarasa, usnavirya, katu madhuravipaka, laghu usna ruksha snigdhaguna / Vatakhapasamaka, sothahara, varnya, sukrala, brmhaniya medhya. / . Qs
2.KSHEERABALATAILA INGREDENTS:
S.NO / DRUG / RASA ,GUNA, VIRYA, VIPAKA. / KARMA. / QUANTITY1 / Bala moola / Madhura rasa, sitavirya, madhuravipaka, guru guna, / bramhaniya / 5 Pala
2 / Goksheer / Madhurarasa, snigdhaguna, madhura vipaka, sitavirya, / Jeevaniya, sukrala, medhya, vajikarana, tridoshasamaka, medhya / 4 Prastha
3 / Tila taila / Aramba tiktarasa , kasayarasa, madhurapaka, usnavirya sukshmaguna. / Bramhana , lekhana, deepana, pachana, soolahara, varnya vrsya. / 1 Prastha
7.2) METHOD OF COLLECTION OF DATA;
a) Study design:
A simple randomized comparative clinical Trial
b) Sample size:
A Minimum of 30 Patient divided into 2 groups. 15 Patients in each group.
Group A: Receives only Guggulu vatakam.
Group B: Receives Guggulu vatakam and Ksheera-bala taila matra vasti simultaneously.
c) Inclusion criteria:
1. Patient between age group of 30 to 70 yrs.
2. Patients suffering from classical signs and symptoms of Sandhigatavata like shotha in sandhi, Shoola in sandhi
3. No discrimination of sex and chronicity and severity of disease
4. Patient fit for basti
d) Exclusion criteria:
1. Patient below 30 yrs & above 70 yrs of age will be excluded.
2. Pregnant women.
3. Inflammatory arthritis, gout, pseudo gout.
4. Severe bursitis (knee studies only)
5. Symptomatic trochanteric bursitis (hip studies only)
6. Acute joint trauma
7. Complete loss of articular cartilage
8. Any systemic disorders other than sandhi gata vata
9. Not Fit for Basti
e) Diagnostic criteria:
Diagnosis is made on the basis of classical symptoms.
f) Posology:
Guggulu vatakam given orally(500 mgtab) twice a day for period of 30 days
Ksheera bala taila matra vasti 50 ml for 7 days.
g) Study duration:
Treatment:
Guggulu vatakam for 30 days
Ksheera bala taila matra vasti 7days with guggulu vatakam for 30 days
Total study duration 30 days
h) Follow up – 10 days
i) ASSESSMENT OF RESULTS:
The subjective and objective parameters of base line data to pre and post medication will be compared for assessment of the results.
j) Subjective parameters:
Ruk (Pain)
01. Grade 0 – No Complaints
02. Grade 1 – Tells on Enquiry
03. Grade 2 – Complains Frequently
04. Grade 3 – Excruciating Condition
Graha (Stiffness)
01. Grade 0 – Absent
02. Grade 1 – Present
Sparshaakshamatva (Tenderness)
01. Grade 0 – No Complaints
02. Grade 1 – Says the joint is tender
03. Grade 2 – Winces the affected joint
04. Grade3 –Winces and withdraws the affected joint.
Shotha (Swelling)
01. Grade 0 – No Complaints
02. Grade 1 – Slightly obvious
03 Grade 2-covers well over the bony prominence
04 Grade 3-Much elevated
Atopa (Crepitations)
01. Grade 0 – None
02. Grade 1 – Felt
03 Grade 2- Heard
All these parameters of baseline data to post-medication data (30th day) will be compared for clinical assessment of the results (assessment will be recorded on every 10th day ).
k) Objective parameters:
1. Hemoglobin %
2. Erythrocyte sedimentation rate:
3. Differential count:
4. Joint pain grading 0 to 10 (VAS)
5. Range of movements
6. Local temperature:
7. Swelling in mm
8. Walking time
9. WOMAC
10.Brief pain inventory
11. X-ray of affected joint
All these parameters of baseline data to post-medication data (30th day) will be compared for clinical assessment of the results.
7.3 INVESTIGATIONS:
1) Hemoglobin%
2) Erythrocyte sedimentation rate.
3) Differential count
4) X-ray of joint.
7.4 Ethical Clearance: Yes obtained and enclosed.
8. List of references:
1. Siddharth N. Shah edited API text book of medicine; chapter 19th; edited 7th; 2003; Pub: The Association of Physicians of India; Page no 1154.
2. Dr.Bramhanand Tripathi edited, Charak Samhita,,Chikitsasthana, chapter 28, Shloka 56th, Vol. 2nd reprint 2005,pub. Choukhamba Surabharati Prakashan ,Varanasi, page no.947.
3. Atrideva edited, Sushrut Samhita, Chikitsasthana, Chapter 35, shloka 4th , 5th edition ,reprent 2002, pub. Motilal Banarasidas, Delhi, page no. 524
4. Shri Ganga Sahaya Pandeya edited, Gada nigraha, vatavyadhi chikitsa, Chapter 19, shloka 157, 159, edition I, pub Chowkhamba Sanskrit Series office Varanasi, Page no 507
5. Sahasrayogam banaras ayurvedic seris 18. A book on Keraliya Ayurvedic Treatment by Dr.K.Nishteswar & Dr.Vidyanath, text with English translation, Chowkhamba Sanskrit series edition 2008.
6. Shastri Ramgopal edited Vedom mein Ayurveda, Delhi Madan Mohanlal Ayurveda Anusandhan Trust, edition-1956 Page no 3.
7. Vaidya Yadavji trikamji Acharya edited Charaka Samita, ChikitsaSthana, Chapter 28, Shloka 206, Edition 2006, Pub Chowkhamba KrishnaDas Academy, Varanasi-Pageno 621
8. Atrideva edited, Sushuta Samhita, Chikitsasthana, Chapter 35, shloka 6th, 5th edition ,reprent 2002, pub. Motilal Banarasidas, Delhi, page no. 525.
9. Prof.K.R.Srikantha Murthy Translated ,Astanga Sangraha, Sutrasthana, Chapter 28th ,Shloka 3rd ,edition 2005, pub. Choukhamba Orientalia, Varanasi, Page no. 485.
10. Ramvalaereba Shastri edited, Harita Samita chapter 20, shloka14 Prachyaprakasan Varanasi, Page no 111
11. Ayurvedacharya Shree Yadunandana Upadhyaya, Madhava Nidana, Part 1,Nidana Sthana, Chapter 22,Shloka 21,Chaukamba Sanskrit Bhawan,P.B.No.1139,K37/116.