RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION IN KAYACHIKITSA. M.D. (AYURVEDA)

“EFFICACY OF SAHACHARADIKASHAYA AND RASNA SHUNTYADIKASHAYA IN JANUSANDHIGATA VATA - A CLINICAL COMPARATIVE STUDY W.S.R.TO KNEE JOINT OSTEOARTHRITIS”

By

DR. MANJULA RANAGATTI

1st Year P.G. Scholar (Ayurveda),

Dept of P.G. studies in Kayachikitsa,

Alva’s Ayurveda Medical College,

Moodbidri, D.K District,

Karnataka. Pin: 574227.

GUIDE

DR. ZENICA D’SOUZA. M.D (Ayu)

Professor & HOD

Dept of P.G. studies in Kayachikitsa

Alva’s Ayurveda Medical College,

Moodbidri, D.K District,

Karnataka. Pin 574227.

2011-2012

Alva’s Ayurveda Medical College, Moodbidri,

D.K District, Karnataka. Pin: 574227

From,

DR.MANJULA RANAGATTI

1st year P.G. scholar

Dept. of P. G. Studies in Kayachikitsa

Alva’s Ayurveda Medical College,

Moodbidri, D.K District,

Karnataka - 574227.

To,

THE REGISTRAR,

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore.

Through,

THE PRINCIPAL,

Alva’s Ayurveda Medical College,

Moodbidri, D.K,

Karnataka

Sub: Submission of completed proforma for registration of subject for

dissertation in M.D (ayurveda).

Respected sir,

I request you to kindly register the below mentioned subject against my name for the submission of dissertation to the Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore, as partial fulfillment of M.D(Ayu) in Kayachikitsa.

Title of Dissertation

“EFFICACY OF SAHACHARADIKASHAYA AND RASNA SHUNTYADIKASHAYA IN JANUSANDHIGATA VATA - A CLINICAL COMPARATIVE STUDY W.S.R.TO KNEE JOINT OSTEOARTHRITIS”

Herewith I am enclosing the completed proforma for the registration.

Thanking you,

Place: Moodbidri. Yours sincerely,

Date: 20-04-2012 Dr. Manjula Ranagatti

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE.

ANNEXURE –II

PROFORMA FOR REGISTRATION OF SUBJECT – DISSERTATION IN

M.D. (AYURVEDA) KAYACHIKITSA

1.  NAME OF THE CANDIDATE

AND ADDRESS : Dr. MANJULA RANAGATTI

1st YEAR P.G. SCHOLAR (AYU),

DEPT. OF P.G. STUDIES IN

KAYACHIKITSA,

ALVA’S AYURVEDA MEDICAL

COLLEGE, MOODBIDRI, D.K

KARNATAKA-574227

PERMANENT ADDRESS : Dr. MANJULA RANAGATTI

NO.358, MAHANTESH NAGAR,

NEAR ABUBKAR DARGA,

JAMKHANDI, BAGALKOT DIST,

KARNATAKA. PIN: 587301

2.  NAME OF THE INSTITUTE : ALVA’S AYURVEDA MEDICAL COLLEGE, MOODBIDRI,

D.K. KARNATAKA – 574227

3.  COURSE OF STUDY AND

SUBJECT : AYURVEDA VACHASPATHI M.D. (AYU) - KAYACHIKITSA

4.  DATE OF ADMISSION

TO THE COURSE : 31-10-2011

5.  TITLE OF THE TOPIC :

“EFFICACY OF SAHACHARADIKASHAYA AND RASNA SHUNTYADIKASHAYA IN JANUSANDHIGATA VATA - A CLINICAL COMPARATIVE STUDY W.S.R.TO KNEE JOINT OSTEOARTHRITIS”

6. Brief resume of intended work:

6.1 Need for the study:

Sandhigata vata is one among the Vatavyadhi and characterized by Vata purna druti sparsha, Shotha, Vedana during Prasarana and Akunchana1, Sandhi Shoola, Atopa and Sandhi Hanti2.

Janusandhigata vata can be compared with Knee joint Osteoarthritis. Osteoarthritis is the second commonest musculoskeletal problem in the world population (30%) after back-pain (50%)3.

Osteoarthritis is the most common form of Arthritis. It shows a strong association with ageing and is a major cause of pain and disability in the elderly. Pathologically, it may be defined as a condition of synovial joint characterised by focal loss of articular hyaline cartilage with proliferation of new bone and remodelling of joint contour4.Knee joint Osteoarthritis is the leading cause of chronic disability in developed countries5.

The formulation Sahacharadi Kashaya6 contains Sahachara,Suradaru and Nagara where drugs are having specificity in Dehagati(druta & vilambita gati . The other formulation Rasna Shuntyadi Kashaya7 contains Rasna, Shunthi, Guduchi, Sahachara, Jalada, Abhiru, Pathya, Shatahwa,Tikta,Kacchura,Vasa,Tilaripu Panchamoola, dwaya(Brihat & Laghu Panchamoola) where drugs are having Ushna Veerya, Vatahara,Shothahara,Vedanasthapana and indicated in Sandhi Peeda. A comparative study between these two formulations will prove a better option in Janusandhigata vata.

6.2 Review of literature:

Available Ayurvedic literatures, contemporary texts from the field of medical science, journals and previous works on disease are referred to obtain the source of data.

Ø  Charaka Samhita

Ø  Sahasrayogam Kashaya and Parisishta Prakaranam.

Ø  Davidson’s Principles and Practice of Medicine.

Ø  API Textbook of Medicine.

Ø  Harrison’s Principles of Internal Medicine.

Previous work done:

1.  Dr. Krishna Veni S. – Management of “Sandhigata vata with Ajamodadi Vati” – A clinical evaluation, 2008, RGUHS, Karnataka.

2.  Dr.Gaurav Sharma - A comparative clinical study on Sandhigata vata with Adithyapaka guggulu and Rasnadi guggulu, 2007, RGUHS, Karnataka.

3.  Dr. Rajarama D K - A clinical study on Sandhigata vata (oa) with reference to Abhadi yoga, Ramya taila and Kunduru lepa, 2005, RGUHS, Karnataka.

4.  Dr.Veena G D - A clinical comparative study on the effect of Gunjaphada lepa and Dhatturapatra lepa with Shudda guggulu as shamanoushadha in Janusandhigata w.s.r to Osteo-arthritis of knee joint, 2005, RGUHS, Karnataka.

5.  Dr.Anil P Varkey- Management of Sandhigata vata with Rasna Panchakam Kashayam a clinical evaluation, 2002, RGUHS, Karnataka.

6 .3 Objective of study

1.  To evaluate the efficacy of Sahacharadi Kashaya in Janusandhigata vata wsr to Knee joint Osteoarthritis.

2.  To evaluate the efficacy of Rasna Shuntyadi Kashaya in Janusandhigata vata wsr to Knee joint Osteoarthritis.

3.  To compare the efficacy of Sahacharadi Kashaya and Rasna Shuntyadi Kashaya in Janusandhigata vata wsr to Knee joint Osteoarthritis.

Hypothesis

H0: There is neither effect of Sahacharadi Kashaya nor Rasna Shuntyadi Kashaya

in Janusandhigata vata wsr to Knee joint Osteoarthritis.

H1: There is effect of Sahacharadi Kashaya and Rasna Shuntyadi Kashaya

in Janusandhigata vata wsr to Knee joint Osteoarthritis.

H2: Sahacharadi Kashaya has got better effect than Rasna Shuntyadi Kashaya in

Janusandhigata vata wsr to Knee joint Osteoarthritis.

H3: Rasna Shuntyadi Kashaya has got better effect than Sahacharadi Kashaya in

Janusandhigata vata wsr to Knee joint Osteoarthritis.

7. Materials and methods

7.1 Source of data:

a. Literary source: Available Ayurvedic literatures, contemporary texts from the field of medical science, journals and previous works on disease are referred to obtain the data for present study.

b. Pharmaceutical source: ‘Sahacharadi Kashaya’ and ‘Rasna Shuntyadi Kashaya’ will be prepared in Alva Pharmacy, Mijar as per text reference.

c. Clinical source: Patients of either sex attending OPD and IPD of Alva’s Ayurveda Medical College & Hospital, Moodbidri and from other available sources who are diagnosed to have Janusandhigata vata will be selected for the study.

7.2 Methods of collection of data

a. Sample size:

Minimum of 40 patients fulfilling the diagnostic and inclusion criteria of either sex irrespective of Caste, Religion, Educational and Socio economical status will be selected. Randomly they will be assigned into two equal groups (Group A and Group B).

A detailed history and examination will be carried out and findings will be noted before, during and after the scheduled treatment. Changes in signs & symptoms will be documented in a specially prepared case proforma.

Study design: Single Blind Randomized Comparative clinical study.

Method of sampling: Lottery method.

b. Intervention:

Group A:

Sample Size / 20 Patients
Medicine / Sahacharadi Kashaya
Dose / 25 ml twice daily before food
Sahapana & Anupana / Eranda Taila & Ushna Jala
Total Treatment Duration / 30 days

Group B:

Sample Size / 20 Patients
Medicine / Rasna Shuntyadi Kashaya
Dose / 25 ml twice daily before food
Anupana / Ushna Jala
Total Treatment Duration / 30 days

c. Observation period:

Treatment period: Patients will be assessed clinically on day 0, 15th and 30th

day of treatment.

Follow up: 45th and 60th day.

Total study duration: 60 days.

d. Diagnostic criteria:

The diagnosis is mainly based on clinical presentation of the patient i.e. signs and symptoms of Janusandhigata vata mentioned in Ayurvedic texts. Radiograph will be taken to confirm the clinical findings.

e. Inclusion criteria

Ø  Patients suffering from signs and symptoms of Janusandhigata vata like

Janusandhi Shoola, Janusandhi Shotha, Janusandhi Atopa with or without other signs and symptoms.

Ø  Patients with radiological findings of Knee joint Osteoarthritis.

Ø  Patient of either sex between age group of 30 to 70 years.

Ø  Both fresh and previously treated cases will be taken.

f. Exclusion criteria

Ø  Osteoarthritis secondary to other conditions like trauma, fractures etc.

Ø  Complete loss of articular cartilage.

Ø  Patients having other systemic disorders which might interfere in the present study.

Ø  Pregnant woman and lactating mother.

g. Assessment criteria:

Subjective parameters:

-  Janusandhi Shoola (Knee joint Pain)

-  Janusandhi Stambha (Knee joint Stiffness)

Objective parameters:

-  Janusandhi Shotha (Knee joint Swelling)

-  Janusandhigati asamarthatha (Restriction in Range of Knee joint

Movements) - Using Goniometer

-  Janusandhi atopa (Crepitus in Knee joint)

-  Janusandhi Sparshaakshamatva (Tenderness in Knee joint)

-  WOMAC Osteoarthritis index.

-  VAS (Visual Analogue Scale)

Assessment will be done by adopting standard scoring methods for subjective and objective parameters and will be analysed statistically using suitable tests.

7.3 Does the study require any investigations or interventions to be conducted on patient or other human or animal? If so describe briefly.

This study will be conducted clinically. No animal experiment will be carried out.

Investigations

Apart from Routine Investigations the following specific investigation will be carried out before the clinical study to confirm the diagnosis.

·  X- Ray of the affected Knee joint – AP and Lateral views.

·  Any other (if necessary).

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Yes, clearance is obtained through ethical committee constituted in the institution.

8. References:

1. Vaidya Yadavji trikamji Acharya edited Charaka Samhita, Chikitsa Sthana,

2006, Chowkhamba Krishna Das Academy, Chapter 28, Shloka 37, Page no 618.

2. Dr.Brahmananda Tripathi,Madhavanidanam of Madhukosha commentary, Vol 1,

2007, Chaukhamba Surbharati Prakashan, chapter 22, Vatavyadhi nidanam,

Page no 520.

3. Edited by Siddharth N.Shah,API Textbook of Medicine,Vol 1,8th edition,2009,The

Associations of Physicians of India, chapter 7, Page no 279.

4. Sir Stanley Davidson, Davidson’s Principles and Practice of Medicine, edited by

John A.A.Hunter et al, 20th edition, Churchill living stone, Page no 1096.

5. Edited by Dennis L.Kasper et al, Harrison’s Principles of Internal Medicine, Vol

2,16th edition, 2005, McGraw-Hill publication, Part 13, Page no 2036.

6. Ram Nivas Sharma and Surendra Sharma, Sahasrayogam, edition 2007,

Chaukhamba Sanskrit pratisthan, Kashaya prakaranam, vatahara kashayam,

Page no 32.

7. Ram Nivas Sharma and Surendra Sharma, Sahasrayogam, edition 2007,

Chaukhamba Sanskrit pratisthan, Parisishta Prakaranam, Page no 260.

9) SIGNATURE OF THE CANDIDATE:

10) REMARKS OF THE GUIDE :

11) NAME AND DESIGNATION OF

11.1) GUIDE : DR. ZENICA D’SOUZA.M.D (Ayu)

PROFESSOR & HOD

DEPT OF P.G. STUDIES IN

KAYACHIKITSA

ALVA’S AYURVEDA MEDICAL

COLLEGE, MOODBIDRI, D.K

KARNATAKA. PIN 574227.

11.2) SIGNATURE AND SEAL :

11.3) HEAD OF THE DEPARTMENT : DR. ZENICA D’SOUZA.M.D (Ayu)

PROFESSOR & HOD

DEPT OF P.G. STUDIES IN

KAYACHIKITSA

ALVA’S AYURVEDA MEDICAL

COLLEGE, MOODBIDRI,D.K

KARNATAKA. PIN 574227.

11.4) SIGNATURE AND SEAL :

12) REMARKS OF THE PRINCIPAL :

12.1) SIGNATURE AND SEAL :

10