From,

Dr. BRIJESH SINGH.

Preliminary M.S. (Ayu) Scholar,

Dept. of Post Graduate Studies in Shalya Tantra,

S.D.M.College of Ayurveda and Hospital,

P.O. Box 164,

Hassan–573201.

To,

The Registrar,

RajivGandhiUniversity of Health Sciences,

Karnataka, Bangalore.

Through,

The Principal and

Head of the Dept. of Post Graduate studies in Shalya Tantra,

S.D.M.College of Ayurveda and Hospital,

Hassan- 573201.

Respected Sir,

Subject: Submission of completed proforma for Registration of Subject for

Dissertation.

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

Title of the Dissertation:“clinical evaluation of laksha guggulu and mukta shukti pishti in the management of osteopenia/ osteoporosis”.

Herewith, I am enclosing completed proforma of synopsis for registration of subject for Dissertation.

Thanking you,

Yours faithfully,

Place: Hassan

Date: 09/09/2010

(DR. BRIJESH SINGH)

RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES KARNATAKA,BANGALORE.

ANNEXURE – II

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the Candidate:dR. BRIJESH SINGH,

and AddressPRELIMINARY M.S. (AYU) SCHOLAR.

(IN BLOCK LETTERS)Dept. of Post Graduate studies

in Shalya Tantra,

S.D.M.College of Ayurveda,

AND Hospital, P.O. Box 164,

HassaN–573201.

DR. BRIJESH SINGH

s/oSRI RAJENDRA BAHADUR SINGH

HARPALGUNJ, SINGRAMAU,

JAUNPUR- 222175

UTTAR PRADESH.

2. Name of the Institution: S.D.M.College of Ayurveda

AND Hospital, Hassan – 573 201.

3. Course of the Study in: M.S. (Ayu), SHALYA TANTRA

SUBJECT

4. Date of Admission to: 14Th JUNE2009

the course

5. TITLE OF THE DISSERTATION: “clinical evaluation of laksha guggulu and mukta shukti pishti in the management of osteopenia/ osteoporosis”.

6. BRIEF RESUME OF THE STUDY:

6.1 need for the study:

Osteoporosis is a generic term referring to a state of decreased mass per unit volume of a normally mineralized bone due to loss of bone proteins.1

Osteoporosis is the most common skeletal disorder in the world, next only to arthritis. In Osteoporosis there is a long latent period before clinical symptoms develop. Most prevalent complications are fractures of vertebral bodies, ribs, proximal femur, humerus,distal radius with minimal trauma.2

Osteoporosis is a silent and progressive disorder. Increased awareness of osteoporosis, especially in postmenopausal woman has, led to increased screening.3The environmental factor such as poor nutrition and low calcium intake, a sedentary life style and exposure to medications including steroids also play a role.4

Osteoporosis is caused by due to prolonged bed rest, prolonged splinting, paralysis, improper nutrition of calcium, vitamin c, protein, chronic alcoholism, prolonged use of drugs like heparin, methotrexate, ethanol, glucocorticoids etc, endocrine abnormalities, genetic role, idiopathic variety is seen in middle age male population.5

According to modern medicine it is managed with, Hormone replacement therapy and also with calcium and vitamin D, which is considered as anti resorptive and stimulator of the bone turn over.6,7 But these drugs do have side effect like nausea, vomiting and diarrhoea. So there is need to find Ayurvedic modalities in osteoporosis.

In Ayurveda under the heading Asthi Kshaya many signs and symptoms described can closely be correlated with this clinical entity. There are many preparations in various context for Asthi Kshaya. So present clinical study is being planned to be conducted to evaluate the effect of Laksha Guggulu and Mukta Shukti Pishti in the management of osteopenia/osteoporosis.

6.2 Review of the literature:

Sushruta has mentioned the Lakshanas of Asthi Kshaya like Asthi Shoola, Rukshata, Danta and Nakha Pata.8

Sushruta has mentioned the Asthi Sankhya, and Prakar in Shareera Sthana.9

Sushruta has mentioned the Asthi Karma, Asthi Sara Purusha in Sutra Sthana.10

Charaka has mentionedLakshanas of Asthi Kshayalike Hair fall, Nakha Pata, Dantasoola, Asthi Soola and Asthi Sandhi Saithilyata.11

Charaka has mentioned the Asthi Sara Purusha, Asthi Vaha Srotas, Dusti Lakshanas and its Nidana in Viman Sthana.12

Vagbhata in Ashtanga Hridayam has mentioned Lakshanas of Asthi Kshaya like Asthi Soola, Danta, Kesha, Nakha Patit and Sounnd in Joints.13

Definition, Pathology, Causes, Clinical features, Investigation, Diagnosis and Management of osteoprosis is defined in Text Book of Orthopaedics.14

The common and specific Nidana of Asthi Dustiare explained in text as Charaka Viman Sthana .15

The Samprapti of Asthi are explained as Samanya Samprapti of Vata Vyadhi.16

Sushruta has mentioned the Asthi Bhagna Chikitsa in the Chikitsa Sthana.17

Charaka has mentioned the Asthi Roga Chikitsa in the Chikitsa Sthana and also in Sutrasthana.18

Research conducted on Asthi Kshayaat differentresearch centers, relevant journals, periodicals, magazines will be reviewed.

Previous Research Works Conducted:

1.Joban.Putra.H.A.: A comparative study in fracture healing w.s.r. to Lakshadi compound(Jamnagar, 1984).

2.Madhuri.Devi.N. : Effect of Laksha on bone T.B.(Trivendram, 2000).

3.Singh.Sumer.: Mukta Bhasma and Pishti Evam Manakee Karana. (Haridwar, 2001).

4. Madhuri.Devi.N.: A clinical study on the effect of laksha in bone healing (Trivendram, 2001).

5. Gupta.B.G.: Asthi Bhagna Par Lakshadi Guggulu Ki Karmukata Ka Adhyayana. (Bidar, 2003).

6.Panwar.B.K.:Pitta Shamana Main Amalaki Rasayana Aur MuktaPishti Ki Karmukata Ka Tulanatmaka Adyayana.(Jaipur, 2002).

7. Shelly.Divya.Darshan.: Critical and comparative study on Asthi Vaha Srotas w.s.r. Asthi Kshaya (Bidar, 2004).

6.3 Objectives of the Study

  • To assess the efficacyof Laksha Guggulu and Mukta Shukti Pishti in the management of osteopenia/osteoporosis.
  • To assess the safety of Laksha Guggulu and Mukta Shukti Pishti in the management of osteopenia/osteoporosis.

7. Materials and Methods

7.1 Source of Data:

50Patientswill be selected from outpatientandinpatient department ofP.G.Studies in Shalya Tantra, S.D.M.college of Ayurveda and Hospital, Hassan.

7.2 Methods of Collection of Data:

Patients will be registered with the help of research proforma prepared for the study.

Diagnostic Criteria:19

Diagnosis will be made on the basis of Lakshanas of osteoporosislike backpain, fracture of axial skeleton, compression of thoracic vertebrae, loss of height, wrist fractures, rib fractures, loss of bony trabeculae and thinning of cortices.20

Inclusion Criteria:

  • Patients of both sexes above 45 years and below 65 years.
  • Patients with osteopenia or spinal deformities in spine-x-rays.
  • Patients with history of osteoporosis related fractures.
  • Quantitative calcaneal ultrasound, ‘T’ score > - 1.0.
  • Assessed using the DEXA scan or calcaneal/ wrist ultrasound
  • Willing and able to participate for 16 weeks.

Exclusion Criteria:

  • Age below 45 and above 65 years.
  • Hypoparathyroidism/Hyper parathyroidism, Hypothyroidism/Hyper thyroidism
  • Malabsorption syndrome andPregnant or lactating woman.
  • Patient whose serum ca++ level < 2.2 or > 2.6 mmol/l (< 9 or > 10.5mg/dl).
  • Any metabolic bone disease e.g. Paget’s disease, Psycho-Neuro-Endocrinal disorder, Rheumatoid arthritis, Osteomalacia, Dysosteogenisis imperfectand Marfan’s syndrome,Cushing’s syndrome or hyperprolactinemia.
  • Patient with history of fragility fracture and Long bone fracture in last 6 months.
  • Chronic liver diseases,Chronic renal failure( GFR <30ml/min/1.73m2)and uncontrolled Pulmonary Dysfunction.
  • Organ transplantation and evidence of malignancy.
  • Prolonged immobilization(≥6 weeks).
  • Alcoholics/drug abusers and hypersensitivity to any of the trial drugs.
  • H/O Atrial fibrillation, Acute coronary syndrome, Myocardial Infarction, stroke or Severe Arrhythmia in last 6 months and clinical evidence of Heart failure.
  • Uncontrolled diabetes mellitus (HbA1c>10%).
  • Patient under any drug which is known to affect bone metabolism SERMs, bisphophnates, calcitonin, Vit.D and carticisteroids for more than 3month.
  • Any other condition which the P.I thinks may jeopardize the study.

Treatment Group:

50 patientsabove the age of 45years and below the age of 70 years fulfilling the criteria for inclusion will bemanaged in single group in the intervention as follows.

Laboratory Investigation: 21

Blood (HB%, TC, DC, ESR) DEXA or calcaneal ultrasound,Serum calcium, Serum Osteocalcin, Bone specific alkaline phosphatase, HbA1c, Thyroid Profile, Serum Vit. D level, Liver function test, Serum creatinine, Serum Electrolytes, Serum Uric acid, Lipid Profile, HIV, HBsAg,Bone Mineral Density (B.M.D.), E.C.G and X-ray – L.S Spine A.P and Lat. View.

Assessment Criteria:

  • Assessment is done on the basis of improvement in signs and symptoms.
  • Patients will be assessed with subjective and objective parameters formulated for osteoporosisbefore and after the every 14 days till the completion of trail treatment.
  • 30% or more in B.M.D. ‘T’ Score (above – 1.5 level) increase will be considered as significant improvement.
  • The B.M.D. will be done before and after the completion of the treatment.

Subjective Parameters: 22

  • To prevent fracture.
  • Tenderness at fracture site.
  • Generalized kyphosis.

Objective Parameters: 23

  • Decrease pain at the site of fracture.
  • Decrease tenderness at the site of fracture.
  • Bone Mineral Density improvement
  • Biochemical improvement before and after treatment

Duration of Treatment:

Duration of treatment is 12 weeks.

Drug/Doses:24, 25

Laksha Guggulu1gm(2 tab. of 500mg) twice/day and Mukta Shukti Pishti 250mg (1 cap. 250mg) twice/day

Anupana: Lukewarm Water

Period of Study:

12 weeks for each case.

Total duration:

Total duration will be 18 months to complete the study.

Follow up Study:

From starting the treatment the patients will be followed at regular intervals of every 14 days.

7.4 Has Ethical Clearance been obtained from your institution?Yes

8. LIST OF REFERENCES

1)Text book of Orthopaedics- By S.Kalava 1st Edition 2004 13th Chapter Page No. 133-134.

2)Essentials of Orthopaedics for Physiotherapists- By John Ebnezar Edition: 1st 2003. Chapter No. 23, Page No. 357-359

3) Text book of Orthopaedics- By Rajesh Malhotra and Surya Bhan.Edition: 1st 2000, 5thChapter Page No. 75-77.

4) Orthopaedic Knowledge Update (7) Home study syllabus - Edited By Kenneth J. Koval.Edition: 1st 2004, 16thChapter Page No.146-151.

5) Essentials of Orthopaedics and Applied Physiotherapy- By Jayant Joshi and Prakash Kotwal.Reprinted 2000, 6th Chapter Page No. 195-196

6)Out line of Orthopaedics-By John Crawford Adams and David.L.Hamblen Edition: 13thPage No. 67-69.

7) A Concise Text book of Surgery- By S. Das Edition: 4th2006.Page No. 211,212.

8) Sushruta Samhita-Purvarda, Edited with Ayurvedic Tatwa Sandipika. By Kaviraja Ambikadutta Shastri Part I 14th Edition -Reprinted 2007 Published by: Chaukhamba Sanskrit Sansthan, Varanasi. Su.Su. 15/13.Page No.58.

9)Sushruta:Purvarda, Edited with Ayurvedic Tatwa Sandipika. By Kaviraja Ambikadutta Shastri Part I 14th Edition -Reprinted 2007 Published by: Chaukhamba Sanskrit Sansthan, Varanasi. Su. Shareera Sthana.5/18. Page No. 43.

10) Sushruta:Purvarda, Edited with Ayurvedic Tatwa Sandipika. By Kaviraja Ambikadutta Shastri Part I 14th Edition -Reprinted 2007 Published by: Chaukhamba Sanskrit Sansthan, Varanasi. Su. Su. 15/7. Page No. 57.

11) Charaka Samhita-Vol–1 By Acharya Vidyadhar Shukla,Prof.Ravidutt Tripathi Edition-2004 Published By: Chaukhamba Sanskrit Pratisthan Delhi Page No. 265. Ch.Su.17/67.

12) Charaka Samhita-Vol–1 By Acharya Vidyadhar Shukla,Prof.Ravidutt Tripathi Edition-2004 Published By: Chaukhamba Sanskrit Pratisthan Delhi Page No. 647. Ch.Vimana Sthana. 8/107.

13) Vagbhata: Astanga Hridayam with english translation and commentoryby T. Sree Kumar. Published by PublicationDepartmentHariSreeHospital Mannuthy Thrissur Kerala. 2nd Edition 2008.Sutrasthana: 11: 19 Page No. 295

14)Essentials of Orthopaedics (Practical diagnosis and management)- By Dr. G.Vijayaragharam Edition: 1st 1999Page No. 12-16.

15)Charaka Samhita-Vol–1 By Acharya Vidyadhar Shukla,Prof.Ravidutt Tripathi Edition-2004 Published By: Chaukhamba Sanskrit Pratisthan Delhi Page No. 647. Ch. Vimana Sthana.8/107.

16)Sushruta: Sushruta Samhita Nibanda Sangraha Commentary of Dalhanacharya Published by Chaukhamba Sanskrit Sansthan, Varanasi. 7thEdition 2002.Chikitsasthana: 1: 7

17) Sushruta: Sushruta Samhita Nibanda Sangraha Commentary of Dalhanacharya Published by Chaukhamba Sanskrit Sansthan, Varanasi. 7th Edition 2002.Chikitsasthana: 4: 7

18)Charaka Chikitsa: Vol–2By Acharya Vidyadhar Shukla,Prof.Ravidutt Tripathi Edition-2005 Published By: Chaukhamba Sanskrit Pratisthan Delhi Page No. 704, 716. Cha.Chi. 28/93& 28/195.

19) Charaka Samhita-Vol–1 By Acharya Vidyadhar Shukla,Prof.Ravidutt Tripathi Edition-2004 Published By: Chaukhamba Sanskrit Pratisthan Delhi Page No. 265. Ch.Su.17/67.

20) Text book of Orthopaedics- By Rajesh Malhotra and Surya Bhan. Edition: 1st 2000, 5th Chapter Page No. 75-76.

21) Orthopaedic Knowledge Update (7) Home study syllabus - Edited By Kenneth J. Koval. Edition: 1st 2004, 16th Chapter Page No.146-151.

22) The Ayurvedic Formulary of India- Second revised English edition 2003, The controller of publications civil lines delhi (110054) Part 2 Group No. 5 Guggulu Preparation Page no.70.

23) Bhaisajya Ratnavali of Govinda Das Bhishagratna- Commented upon by Vaidya Sri Ambika Datta Shastri. Volume 2 English Translation by Dr.Kanjiv Lochan, Choukhambha Sanskrita Sansthan Varanasi Edition 2009 Reprinted 49th Chapter, Page No. 774 Shloka No. 13-14.

24) Shiddha Yoga Samgraha- by Dr. Omkar Dutta Sharma Krishna Das Academy Varanasi 5th edition, Published by Choukhamba Press Varanasi 3rd Chapter Page No.298-299.

9. Signature of the Candidate :

10. Remarks of Guide:

11. Name and Designation of:

(IN BLOCK LETTERS)

11.1 Guide :DR.GOPIKRISHNA. B. J

M.S. (AYU), (PhD)

ASST. PROFESSOR, DEPARTMENT OF P. G.

STUDIES IN SHALYATANTRA,

S. D. M. COLLEGE OF AYURVEDA AND

HOSPITAL, HASSAN.

11.2 signature:

11.3 Co-Guide:

11.4 Signature:

11.5 Head of the Department: DR. P. HEMANTHA KUMAR

M.S. (AYU), IMS, BHU, PhD

PROFESSOR AND HEAD OF THE

DEPARTMENT,

P. G. STUDIES IN SHALYA TANTRA, S.D.M.COLLEGE OF AYURVEDA

AND HOSPITAL, HASSAN.

11.6 Signature:

12.1 Remarks of the

Chairman and Principal:

12.2 Principal:DR. PRASANNA N. RAO

M.S. (AYU), IMS, BHU, PhD

S.D.M.COLLEGE OF AYURVEDA AND

HOSPITAL, HASSAN – 573 201

12.3SIGNATURE:

1