RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BENGALURU

SYNOPSIS BY Dr. USHA M FOR THE DEGREE OF AYURVEDA VACHASPATI M.D. (AYURVEDA) IN RASASHASTRA

TITLE OF THE TOPIC PHARMACEUTICO ANALYTICAL STUDY OF SWARNA BHASMA AND EXPERIMENTAL EVALUATION OF ITS NOOTROPIC ACTIVITY

NAME OF THE INSTITUTE GOVERNMENT AYURVEDIC MEDICAL COLLEGE, DHANWANTARI ROAD, BENGALURU-560009 KARNATAKA

From, Dr. USHA M I yr M.D.(Ayu) Scholar Department of Post Graduate Studies in Rasashastra, Government Ayurvedic Medical College, Bengaluru -09. To, THE REGISTRAR (EVALUATION) Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka.

Through, The Principal and H.O.D of Post Graduate Studies in Rasashastra, Government Ayurvedic Medical College, Bengaluru-09. Respected Sir, Sub: Submission of completed proforma for registration of subject for dissertation. I request you to kindly register the below mentioned synopsis which has been reviewed and submitted for registration of dissertation to the Rajiv Gandhi University of Health Sciences, Bengaluru for the partial fulfillment of M.D(Ayu) in Rasashastra. TITLE OF THE DISSERTATION: PHARMACEUTICO ANALYTICAL STUDY OF SWARNA BHASMA AND EXPERIMENTAL EVALUATION OF ITS NOOTROPIC ACTIVITY. Herewith, I am enclosing completed proforma for registration of the subject for dissertation. Thanking you, Yours faithfully Place: Bengaluru Date:
2

[DR.USHA M]

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BENGALURU

ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the Candidate and Address

Dr. USHA M M.D.(Ayu) Scholar, Dept. Of PG Studies in Rasashastra, Government Ayurvedic Medical College, Bengaluru-560009

Dr. USHA M D/O Nagaraja M Maruthi sadhana Someshwara Nagara K.V.O.R .Colony H.B .Halli (Taluq) Bellary-583212 2. Name of the Institution Government Ayurvedic Medical College, Dhanwantari Road, Bengaluru-560009

3. Course of Study and Subject

M.D.(AYU) IN RASASHASTRA

4. Date of Admission to Course

17/10/2012

5. Title of the Topic

PHARMACEUTICO ANALYTICAL STUDYOF SWARNA BHASMA AND EXPERIMENTAL EVALUATION OF ITS NOOTROPIC ACTIVITY.

6. BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR THE STUDY Rasashastra, being a tribute of Ayurveda deals with standard herbo-mineral preparations along with description of different minerals, metals and gems used in the healing practices of Ayurveda with ultimate objective of promoting health. Metals/minerals have been used as medicines after their shodhana and marana for the treatment of various diseases including mano vikaras and many of them have been experimentally evaluated for their pharmacological efficacy. Among the metals described, SWARNA-asara3/shuddha loha1a/noble metal possesses the properties such as Vishagadaharam, Brumhana, Vrushya, Yakshonmada prashamana, Deharoga Pramathi, Sarvadosha-amayaghnam, Ojovardhaka, etc. and also it is admired to be the best Medhya(smruthidayaka) 1b. Memory is the ability of an individual to record sensory stimuli, events, information etc., retain them over short or long duration and recall the same at later date when needed4.Amnesia refers to acquired global impairment of intellect, memory and personality(conginitive functions) in the absence of gross clouding of consciousness or motor involvement. Nootropics are the cognitive enhancers or nutraceuticals that are purported to improve mental functions, such as cognition, memory, intelligence, motivation and concentration. This medhya action is provided by Swarna Bhasma. Poor memory, lower retention and slow recall are common problems in todays stressful and competitive world. Works to evaluate and bring about effective safe Nootropic drugs are the need of the hour. Hence, the present work will be carried out under the heading of PHARMACEUTICO ANALYTICAL STUDY OF SWARNA BHASMA AND EXPERIMENTAL EVALUATION OF ITS NOOTROPIC ACTIVITY.

6.2 REVIEW OF LITERATURE DRUG REVIEW

Swarna, Gairika, Saindhava lavana, Gandhaka, Hingula & Parada. Information regarding above mentioned raw drugs, their identification, grahya lakshanas, shodhana, marana, etc. will be reviewed and collected from all the available rasa texts and also collection of data from different texts of Mineralogy/Geology.

PROCESS REVIEW Samanya1c&Vishesha Shodhana1f of Swarna Marana of Swarna1d Shodhana of Gairika1e, Gandhaka2c and Hingula2a Extraction of Parada from Hingula2b Preparation of Rasasindura by Kajjali -Kupipakva method2d.

DISEASES REVIEW Relevant information regarding Amnesia will be reviewed and documented in detail from texts of modern medicine.

EXPERIMENTAL REVIEW All relevant information regarding the method of experimental evaluation of Nootropic activity will be reviewed and compiled from standard pharmacology texts.

PREVIOUS WORKS DONE:1) Dr. Srinivas Yadav K.(2003)-Preparation and analytical study of Swarna Bhasma(JSS College Mysore) 2) Dr. Mahesh D(2006)- A Pharmaceutical and analytical study of Swarna Parpati(JSS College Mysore) 3) Dr. Sangeeta Rao (2006) Pharmaceutical and analytical study on Hemagarbha pottali(JSS College Mysore). 4) Dr.Elchuri Raja Ranjith Lenin (2006)-A Pharmaceuticals and analytical study on Makaradwaja (JSS College Mysore). 5) Dr. Sunitha(2008)-Pharmaceutical and Analytical study of swarna sindoora (T.G.A.M.College,Bellary) 6) Dr. Vinamra Sharma (2012)-Toxicity study of Swarna Bhindu Prashana in Albino rats(K.L.E.University,Belgaum). 7) Dr. Ajay Chavan (2012)-Immuno modulatory study of Suvarna Bindu Prashana in Albino Rats (K. L. E. University, Belgaum).

6.3 OBJECTIVES OF THE STUDY : To carry out: 1. Gairika shodhana as per Rasa Ratna Samuchchaya1e. 2. Hingula shodhana done by giving bhavana with nimbu swarasa in khalwa yantra as per Rasatarangini2a. 3. Extraction of Parada from Hingula by urdhwapatana yantra2b. 4. Shodhana of Gandhaka by using bhudharayantra2c. 5. Preparation of Rasa Sindura by kajjali as explained in Rasatarangini2d. 6. Samanya1c & Vishesha shodhana1fof Swarna as per Rasa Ratna Samuchchaya. 7. Swarna Bhasma as per Rasa Ratnasamuchchaya1d. 8. Physico chemical analysis of Swarna Bhasma. 9. Evaluate the Nootropic effect of Swarna Bhasma.

7.0 MATERIALS AND METHODS

7.1 SOURCE OF DATA: Source of Drug: Required genuine Swarna (24 carat Gold) & other genuine raw materials will be procured from recognized authenticated sources and data pertaining to these will be recorded Preparation of formulation: Necessary processing of raw material and preparations will be carried out in Pharmacy of Post Graduate Department of Rasashastra, Government Ayurvedic Medical College, Bengaluru.

Source of Animals: Healthy Wistar Albino rats will be procured from registered animal house.

Place of Work: 1. Preparation of Swarna Bhasma will be carried out in the Department of Rasashastra, Government Ayurvedic Medical College Bengaluru. 2. Basic analytical study will be carried out at Accredited Laboratory. 3. Animal study will be carried out at S. D. M. center for Research in Ayurveda and Allied Sciences, Kuthpady, Udupi-574118.

7.2 METHOD OF DATA COLLECTION 1) Literary Study a. All the relevant available classical and modern literature along with previous research works on Swarna (Gold) will be reviewed and collected. b. All the literature pertaining to the procedure and tests followed to standardize will be reviewed.

2) Pharmaceutical study: a. Genuine raw material will be collected from the authenticated source. b. Samanya Shodhana of Swarna by Nirvapa of Swarna patras in Taila, Takra, Gomutra, Aranala (kanji) and Kulattha kwatha successively for 7 times in each media1c. c. Gairika shodhana will be done by giving bhavana with godugdha1e. d. Vishesha shodhana of Swarna: Thin patras of Swarna are taken and mixture of Gairika and Saindhava lavana is applied over them .These are kept in sharava samputa, heated in midst of fire for one and half hour1f. e. Hingula shodhana will be done by giving Bhavana with Nimbu swarasa for 7 times in khalvayantra2a. f. Extraction of Parada from Hingula will be done by urdhwapatana yantra2b. g. Gandhaka Shodhana will be done by using bhudarayantra2c. h. Preparation of Rasasindura by using samaguna balijaritha Kajjali2d. i. SwarnamaranaRasasindura (1/4th part of swarna) is taken and triturated with amladravya, After making a fine paste, this is applied on both sides of the shodhita swarnapatras then placed in a sharava and subjected to kukkutaputa. This procedure is repeated for 8 times, to secure swarnaBhasma1d.

3. Analytical Study. As per the parameters mentioned in assessment criteria, analytical studies will be conducted on prepared Swarna Bhasma in authorized laboratory.

ASSESSMENT CRITERIA

- All Bhasma Parikshas, (Rekhapurnata, Varitara, Apunarbhava, etc) mentioned in Rasa texts.
- Prepared

drug will be subjected to following tests.

A) Organoleptic tests Colour Taste Smell Consistency

8

B) Physico-chemical Analysis Loss on drying at 1100C Total Ash value Acid insoluble Ash value Water soluble Ash value Determination of pH

C) Chemical Tests Quantitative and Qualitative assay of elements present. D) Special Instrumental methods - XRD -SEM-EDAX 4) Experimental Study: Methodology for animal studies: Scopolamine induced Amnesia in Albino Rats Animal storage condition-Rats will be housed in a well-ventilated room, fed with standard rodent pellet diet and tap water ad libitum. Inclusive criteria: Adult Normal Wistar albino rats of either sex weighing between 150-200 gm. Exclusive criteria: Rats with detectable deformities, underweight/obese and pregnant rats are exclusive criteria. Mode of administration: Oral route Dose:-The human dose of test drug will be converted into Albino rats dose by using standard dose converting formula9. Rat Dose = Human dose x Surface area factor 0.018 x 5, it gives per kg body weight dose.

Grouping: 7 Groups are selected with 6 animals in each.

Normal Control administered with distilled water (10ml/kg) GROUP 1 Standard administered with Piracetam (200mg/kg body wt.) GROUP 2 Swarna Bhasma combined with Vacha, Grutha and Madhu GROUP 3

Swarna Bhasma TED( 2.8mg/kg) GROUP 4

Swarna Bhasma TED X 2(5.6mg/kg) GROUP 5

Amnesia Induced + Swarna Bhasma TED(2.8mg/kg) GROUP 6

Amnesia Induced + Swarna Bhasma TEDX 2 (5.6mg/kg) GROUP 7

Parameters to be evaluated: Histological examination of brain with focus on Hippocampal region.

10

Evaluation of the Drug Action: Amnesia is induced with Scopolamine (0.4mg/kg.) in groups 6 and 7. All rats in groups 4, 6, & 5, 7, would receive Swarna Bhasma in dose of TED and 2 TED, respectively for 7 days, orally. All rats in groups 3 would receive Swarna Bhasma along with Vacha, Grutha and Madhu. On the 7th day , 60 min after treatment of last dose each rat would be subjected to - Elevated Plus-Maze Test. -Morris Water Maze Test. These tests will be conducted for 10-15 days. After 10 days learning & memory task will be assessed. The procedure, technique and endpoint for testing memory shall be followed as per the parameters described by the investigators working in the area of Psycho pharmacology5, 6, 7, 8. Clinical observationRats of all the groups will be observed clinically for general physiological activities like-feed, water intake, general behavior, alertness, bowel habits, and change in body weight.

Statistical AnalysisThe data would be expressed in the form of Mean+ SEM. Suitable statistical methods would be employed for determining the significant level of the observed activity one way ANOVA with Dunnets multiplet test would be used as post hoc test. Graph pad3 software would be used for this purpose.

7.3 Does the study requires any investigation or intervention to be conducted on patients or other humans or animals if please describe. Yes. The present study is planned to be conducted on animals.

7.4 Has ethical clearance has been obtained from your institution in case of 7.3? Applied
11

8 LIST OF REFERENCES1. Vagbhatacharya, Rasa Ratna Samucchaya, Hindi teeka by Ambika Datta Shastri, Choukhambha Sanskrit Bhavan, Varanasi, II edn: 1996, 1a) Ibid chapter 5, verse: 1, page no-95. 1b) Ibid chapter 5, verse: 10, page no-96. 1c) Ibid chapter 5, verse: 29, page no-99. 1d) Ibid chapter 5, verse: 16, page no-97. 1e) Ibid chapter 3, verse: 49, page no- 70. 1f) Ibid Chapter 5, verse: 12, page no 96. 2. Shri Sadanandasharma. Rasatarangini, edited by Kashinath vaidya, Hindi commentary by Dharmananda Shastri, New Delhi: Motilal Banarasidas Publication,11th edition , 2a) Ibid, 9th Taranga, verse 16-17, pg no-202. 2b) Ibid, 5th Taranga, verse 38-42, pg no 82 to 83. 2c) Ibid, 8th Taranga, verse 13-17, pg no177 to 178. 2d) Ibid, 6thTaranga, verse 168-176, pg no 136 to 137. 3. Shrimad govindha Bhagavad pada, Rasa Hrudaya Tantra, Samskrutha teeka by Chaturbhuja Mishra,KrishnaGopala Ayurveda Bhavan,Ajmer,Iedn,9 Avabhoda,verse5,page no-154 4. Milind Parle and Mani Vasudevan. Memory enhancing activity of Abna: An Indian ayurvedic poly-herbal formulation. J health sci 2007;53:43-53. 5. Kulkarni SK, Hand Book of Experimental Pharmacology.3rded. New Delhi: Vallabh Prakashan; 2003.143-46. 6. Dhingra Dinesh, Parle Milind & Kulkarni S K, Memory enhancing activity of Glycyrrhiza glabra in mice, J Ethnopharmacol, 91(2004) 361. 7. Jaiswal A K & Bhattacharya S K, Effects of Shilajit on memory, anxiety & brain monoamines in rats, Indian J Pharmacol,24(1992)12. 8. Morris R.Developments of a water maze procedure for studying spatial learning in the rat. J.Neurosci. Methods. 1984; 11:47-60 9. Ghosh M.N, Fundamentals of experimental pharmacology, Chapter 30, 3rdedition, Kolkota, Hilton and Company, 2005, page no-192.
12

9. SIGNATURE OF THE CANDIDATE 10. REMARKS OF THE GUIDE

11. NAME AND DESIGNATION OF THE GUIDE

DR. SHOBHA.G.HIREMATH. M.D.(AYU), PhD(R.S) BHU PROFESSOR & H.O.D Dept. Of P.G Studies in Rasashastra, Government Ayurvedic Medical College, Bengaluru.

11.1SIGNATURE OF THE GUIDE 11.2. CO-GUIDE (IF ANY) DR. B. RAVISHANKAR Ph.D (Pharmacology) DIRECTOR, S.D.M Centre for Research in Ayurveda and Allied Sciences, Kuthpady, Udupi-574118 11.4. SIGNATURE OF CO-GUIDE 11.5. NAME & DESIGNATION OF H.O.D DR. SHOBHA.G.HIREMATH. M.D.(AYU), PhD(R.S) BHU PROFESSOR & H.O.D Dept. Of P.G Studies in Rasashastra, Government Ayurvedic Medical College, Bengaluru. 11.6. SIGNATURE OF H.O.D 12 12.1. REMARKS OF THE PRINCIPAL 12.2. SIGNATURE OF THE PRINCIPAL

13