VI.BRIEF RESUME OF INTENDED WORK:

6.1) Need for the study: -

Ayurveda the science of life insists upon equilibrium state of all elements like dosha, agni, dhatu, mala, atma, mana and indriya. Health according to Ayurveda is not merely freedom from diseases but a state of excellence and harmony for body, mind and soul.

The function of Asthi Dhatu is to support the body along with nourishing majja. Asthi kshaya is a condition in which there is kshaya of Asthi dhatu. Dalhana has aptly defined kshaya as “swapramanahaani” whereas chakrapanidatta describes it as “rhasaha” and “nyunatvam”. These three words together are sufficient to explain the concept of Asthi kshaya.

Principally whenever there is prakruta dhatu, their respective upadhatu and mala are said to be prakruta at the same time whenever there is kshaya of dhatu their respective upadhatu and mala kshaya will be there. Whenever there is kshaya of asthi dhatu it may lead to severe hairfall, brittleness of nails, falling of teeth. Acharya vagbhata points out that “Asthi is aashraya sthana of vayu”. Asthi and vayu in bones are in inverse relationship, so that factors that increase vata dosha decrease bone mineral density.

Here the “Asthi kshaya” can be compared to osteoporosis. Osteoporosis is a condition of low bone mass density and micro architectural disruption of Bones that results in bone fractures with minimal trauma. The actual prevalence of osteoporosis remains unknown because of its asymptomatic nature. Between 30-50% of women and between 15-30% men suffer fracture related to Osteoporosis. In India it has been presumed that 35% of post – menopausal women are at risk of developing osteoporosis. Osteoporotic fractures commonly occur at the spine, hip and wrist. On an average a post – menopausal woman has 40 – 50% chance of hip fracture in her life time. More than 10% of hip fracture victims die within one year of fracture event from various complications.

In modern Science, supplementation of calcium as well as hormonal therapy are advised. It seems that modern medicine is concentrating more on mineral rather than osteoid diagnosis.

Ayurveda gives more weightage to osteoid and treats osteoporosis with snigdha dravya chikitsa. This appears more appropriate in view of the fact that osteoid is formed first which is then followed by the deposition of mineral in relation to fibres with the help of asthi dhatu.

Asthi kshaya is one of the vataja vikara, Ayurveda believes not only in supplementing calcium but also gives importance to rectifying dhatwagni by using shamanoushadi along with basti chikitsa.

An attempt will be made to provide the required dhatu and ignite the dhatwagni.The very idea is not only to strengthen the bones but to provide good nourishment at the dhatu level. It is hoped that an economic easily available and affordable formulation will be provided to all the subjects who are going to be included for clinical trial.

Here total 50 subjects will be taken for clinical study with 25 subjects in each group. Subjects will be incidentally selected and randomly categorized into two groups.Group A will receivematra basti with Chandanabalalakshadi taila and laksha guggulu. Group B will receive matra basti with Chandanabalalakshadi taila and abhadi guggulu.

6.2) REVIEW OF LITERATURE:

  1. Explanation of Asthikshaya.1,2,3,4,5
  2. Exlanation of Osteoporosis.6,7,8
  3. Matra Basti.9,10,11,12
  4. Chandanabalalakshadi taila.13
  5. Laksha Guggulu.14
  6. Abhadi Guggulu.15
  7. Moorchita Tila Taila16.

PREVIOUS WORK DONE:

  1. 1.Dr.Sharma.B.N- Role of certain indigenous drugs in infections of bone (asthi vidradhi). B.H.U. Varanasi- 1967
  1. Dr.Dubey.P.K- Asthi vignyaniyam. Gwalior Govt.Ayurveda college. Jiwaji University – 1989.
  1. Dr.Sharma.D.R- Ayurveda ke anusar asthi vimarsha N.I.A Jaipur- 1990
  1. Dr.Bhat.M.G- concept of dhatu and dhatwagni w.s.r to asthi dhatu and asthyagni. G.A.U. Jamnagar – 1995.
  1. Dr.T.K.Girija laxmi- A Clinical study on the efficacy of Yoga Basti and Gandha taila in Asthi Soushirya w.s.r Osteoporosis by Ayurveda Maha Vidyalaya RGUHS, Hubli .2003.
  1. Dr,Kathawate Rahul -To study Efficacy of Chandana bala Lakshadi taila matra Basti in Asthi kshaya. Tilak Ayurveda Mahavidyalaya Pune 2003.
  1. Dr.Sanjay kadlimatti- A Clinical evaluation of Asthikshaya w.s.r. Osteoporosis and its management through Ksheera basti and Tab. Calcipral. Ayurveda Maha vidyalaya. Hubli 2006.
  1. Dr.Suresh Suban- Clinical study to evaluate the effect of Madhumalini vasantha in Asthikshaya w.s.r Osteoporosis by Sri DGM college. GADAG.2008.

6.3.OBJECTIVES OF STUDY:

  1. To understand the concept of Osteoporosis according to Ayurveda and Modernmedicine.
  1. To know the causes of Osteoporosis in detail according to Ayurveda and Modernmedicine.
  1. To assess the effect ofmatra basti with Chandanabalalakshadi taila (kala Schedule).
  1. To assess the effect of Laksha guggulu in the management of asthi kshaya.
  1. To assess the effect of Abhadi guggulu in the management of asthi kshaya.

VII. MATERIAL AND METHODS:

The present study titled “CLINICAL MANAGEMENT OF ASTHI KSHAYA(OSTEOPOROSIS) THROUGH MATRA BASTI, LAKSHA GUGGULU AND ABHADI GUGGULU – A COMPARATIVE STUDY” is a clinical trial to assess efficacy ofmatra basti with Chandanabalalakshadi taila, along with Laksha guggulu and Abhadi guggulu.

7.1. SOURCE OF DATA:

The patient attending the OPD and IPD of PG department of kayachikitsa, Ayurveda Mahavidyalaya, Hubli will be taken for study.

7.2. METHOD OF COLLECTION OF DATA:

  1. The patients attending the OPD and IPD, PG Department of Kayachikitsa, Ayurveda Mahavidyalaya Hospital, Hubli will be taken for clinical trial.
  2. Clinical evaluation of patients will be done by collection of data/information obtained by history, clinical findings obtained by physical examination and laboratory test.
  3. Review of literature will be collected from library of PG Department of Kayachikitsa, Ayurveda Mahavidyalaya, Hubli will be taken for study.
  4. Information regarding the topic will be collected from Brahat trayi, Laghu trayi, recent commentaries,authentic journals and websites.
  5. The drugs required for the clinical study will be procured and prepared in the department of Rasa Shastra and Bhaishajya Kalpana, Ayurveda Mahavidyalaya, Hubli.

INCLUSION CRITERIA:

  1. Subjects presenting with classical features of asthi kshaya.
  2. Subjects presenting with osteoporosis on X-Ray.
  3. Subjects of both the sexes and of age group between 25-60 yrs.
  4. Subjects whose Bone mineral densityBMD is, Tscore <-2.5.

EXCLUSION CRITERIA:

  1. Subjects less than 25 years and more than 60 years of age.
  2. Subjects who are on hormonal therapy, avascular necrosis, carcinoma of bone.
  3. Subjects with the known case of metabolic disorders such as Diabetes Mellitus, Hyperthyroidism, Thyrotoxicosis, Paget’s disease, Cushing’s syndrome, Renal, Hepatic, Cardiac, CNS and Endocrinal disorders, Gouty arthritis and Hypertension.
  4. Steroid induced osteoporosis, Pregnant women and Subjects who are unfit for Basti.

PARAMETER OF STUDY:

SUBJECTIVE PARAMETERS:

  1. Asthi Toda - Pain in the bony Area.
  2. Sandhi Shaithilya -Laxity of joints.
  3. Kesha Pratana - Falling of Hair.
  4. Danta pratana - Falling of teeth.
  5. Nakha pratana -Loss and breaking of Nails.

OBJECTIVE PARAMETERS:

  1. BMD
  2. X-Ray Pelvis
  3. Blood-Serum calcium

Assessment criteria:

  1. Improvement in subjective and objective parameters of Asthi kshaya (Osteoporosis), before and after the treatment.
  2. Change in the BMD Test.
  3. Change in the serum calcium.

The results will be categorized as,

  • Marked relief - Above 75% improvement.
  • Moderate relief - 50% - 75% improvement.
  • Mild relief - 25% - 50% improvement.
  • No relief - Below 25% improvement..

The data which are obtained by the clinical trial will be statistically analyzed by applying required statistical test.

STUDY DESIGN:

Sample Size:

AMinimum of 50 Subjects diagnosed as Asthi Kshaya will beincidentally selected and randomly categorized in two groups, namely Group A,Group B and each consisting of 25 Subjects.

Group A:

  • Ama pachana with trikatu Churna 5gm BID 30 minutesbefore foodwith Ushnodaka as Anupana till nirama lakshana seen.
  • Matra basti with Chandanabalalakshadi taila40ml for 16 days
  • Laksha guggulu 1 tab B.I.D with ushna dugdha as anupana for 45 days.
  • Pathya Aahara and Pathya Vihara will be advised to all the Subjects.

Group B:

  • Ama pachana with trikatu Churna 5gm BID 30 minutesbefore foodwith Ushnodaka as Anupana till nirama lakshana seen.
  • Matra bastiwith Chandanabalalakshadi taila 40ml for 16 days
  • Abhadi guggulu 1 tab B.I.D with ushna dugdha as anupana for 45 days.
  • Pathya Aahara and Pathya Vihara will be advised to all the Subjects.

Duration-Three months.Follow up- Once in fortnight.

All the subjects of groups will be advised to see investigator fortnightly during period.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.

YES

INVESTIGATIONS:

  1. BMD Test
  2. Blood – Serum calcium
  3. Blood routine
  4. Urine routine
  5. X-Ray - Pelvis

INTERVENTION:

Group A

  • Ama pachana with trikatu Churna 5gm BID 30 minutesbefore foodwith Ushnodaka as Anupana till nirama lakshana seen.
  1. Basti karma.
  • Poorvakarma :

Sthanika Abhyanga with moorchita Tila Taila over Udara, parshwa, kaksha, kati Pradesha and swedanawill be done.

  • Pradhana karma :

The subject is made to lay in left lateral position and Matra Basti with Chandabalalakshadi taila 40 ml is given for 16 days.

  • Paschat karma:

After the administration of Basti 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.

  1. Shamanoushadi.

Laksha guggulu 1 B.I.D daily along with ushna dugdha as anupana for 45 days.

Group B

  • Ama pachana with trikatu Churna 5gm BID 30 minutesbefore foodwith Ushnodaka as Anupana till nirama lakshana seen.
  1. Basti karma.
  • Poorvakarma :

Sthanika Abhyanga with moorchita Tila Taila over Udara, parshwa, kaksha, kati Pradeshaand Swedanawill be done.

  • Pradhana karma :

The subject is made to lay in the left lateral position and Matra Basti is given with Chandanabala lakshadi taila 40 ml for 16 days.

  • Paschat karma:

After the administration of Basti ,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.

  1. Shamanoushadi.

Abhadi guggulu 1 B.I.D daily along with ushna dugdha as anupana for 45 days.

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

YES

Ethical clearance has been obtained by the ethical committee constituted by Ayurveda Maha Vidyalaya, Hubli, and written consent will be taken byeach individual patient or by an attendant if the patient is illiterate, on a printed consent form.

LIST OF REFERENCES:

  1. Trikamji Yadavji , Charaka Samhita of Agniveshawith Ayurveda dipika commentary of Chakrapani Datta, fourth edition 1994, Chaukhambha samsthanVarnasi,Sutra sthana-17/67, P-103
  2. Trikamji Yadavji,Charaka Samhita of Agnivisha with Ayurveda dipika commentary of Chakrapani data,Fourth edition 1994, Chaukhambha samsthan Varnasi, Vimana sthana-5/17,P-25.
  3. Trikamji Yadavji,Sushrutha Samhitha ,with Nibanda Sangraha commentary of Dalhancharya ,9th edition -2007, Chaukhambha orientalia Varnasi,Sutra sthana 15/9, P-69
  4. Shastri Hari Paradakara, Astanga Hrudayam with the commentaries of Arundatta and Hemadri,Reprint 9th edition-2005,Chaumkhambha oreintalia Varanasi, Sutra sthana -11/19,P-185.
  5. Trikamji Yadavji,Sushrutha Samhitha, with Nibanda Sangraha commentary of Dalhancharya,9th edition -2007,Chaukhambha orientalia Varnasi,

Sutra sthana -42/11,P-186.

  1. Dr.Eugen Braunwald,Dr.DennisKasper,Dr.Anthony Fauci,Dr.Stephen Hauses,Dr.Dan Longo, Dr.J.Larry Jameson; Harrison’s Principles Of Internal Medicine; 17thedition, 2008;Mc Graw Hill, Medical Publishing Division; Volume II, P-2397-2408.
  2. Sir Stanley Davidson, Edited by Niholas A. Boon, Nicki R. Colledge, Brian R.Walker. Davidson’s Principles & Practice of Medicine. 21th edition. London: Churchill Livingstone; New York, 2010, P- 1121-1126.
  3. Sainani G.S.et.al., API Text book of Medicine, 8th edition-2008, Siddhatrh N. Shah(ed), The Association of Physicians of India, Mumbai, P-226-229.
  4. Trikamji Yadavji,Charaka Samhita of Agnivisha with Ayurveda dipika commentary of Chakrapani data,Fourth edition 1994, Chaukhambha samsthanVarnasi ,

Siddhi sthana-4/52-54, P-701,

  1. Shastri Hari Paradakara, Astanga Hrudayam with the commentaries of Arundatta and Hemadri, Ninth edition Reprint-2005, Chaumkhambha oreintalia Varanasi,

Sutra sthana -19/67-69, P-283.

  1. Trikamji Yadavji, Sushrutha Samhitha, with Nibanda Sangraha commentary of Dalhancharya,9th edition -2007, Chaukhambha orientalia Varnasi

Chikitsa Sthana -35/18, P-526.

  1. Trikamji Yadavji, Sushrutha Samhitha, with Nibanda Sangraha commentary of Dalhancharya,9th edition -2007, Chaukhambha orientalia Varnasi ,

Chikitsa Sthana -37/55-57,P-534.

  1. Indradev Tripathi, Yogaratnakara with vaidyaprabha Hindi commentary,Print-2011,Chaukhambha Krishnadas Academy Varanasi P-300, versa 141-148.
  2. Indradev Tripathi,Yogaratnakara with vaidyaprabha Hindi commentary, Print-2011,Chaukhambha Krishnadas Academy Varanasi P-624, versa 23.
  3. Indradev Tripathi, Yogaratnakara with vaidyaprabha Hindi commentary, Print-2011, Chaukhambha Krishnadas Academy Varanasi, , P-624, versa 26.
  4. Kaviraj Ambikadatta Shastri Ayurvedacharya, Bhaishajyaratnavali of Govind Das, 20th edition- 2010, Chaukhambha Prakashan Varnasi, P-185-186.