Impact factor: 0.3397/ICV: 4.10 108 Pharma Science Monitor 6(4), Oct-Dec 2015 PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES Journal home page: http://www.pharmasm.com A CLINICAL STUDY TO ASSESS THE EFFECT OF SAMVARDHANA GHRITA AND YOGA BASTI IN CEREBRAL PALSY Satyawati Rathia 1 *, V. K. Kori 2, Rajagopala S. 2, K. S. Patel 3, Suhas A. Chaudhary 4 1 Ph.D. Scholar, Dept. of Kaumarbhritya, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar - 361 008, India 2 Assistant Professor, Dept. of Kaumarbhritya, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar - 361 008, India 3 Professor, Dept. of Kaumarbhritya, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar - 361 008, India. 4 Lecturer, Dept. of Kaumarbhritya, Shree Gulabkunverba Ayurveda Mahavidyalaya, Gujarat Ayurved University, Jamnagar - 361 008, India. ABSTRACT Cerebral palsy refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination.the prevalence of Cerebral Palsy among children is 2 per 1000 live births. In this study 8 patients were completed the treatment. Samvardhana Ghrita orally for 62 days and Udvartana (5days), Abhyanga (5days), Swedana (5days), and Yoga Basti (8 days) given for 86 days. Total 3 courses were done followed by 16 days interval between each course. Personal & Social milestone was improved. Yoga Basti shown improvement in growth (Height, Wei ght and Mid Arm Circumference), development milestone (sitting, standing, fine motor and personal and social).this study shows that improvement was observed in 12.5% patients. Ayurvedic treatment modality was effective in improving the milestones of Cerebral Palsy patients. KEYWORDS: Abhyanga, Cerebral Palsy, Samvardhana Ghrita, Swedana, Udvartana and Yoga Basti. INTRODUCTION Childhood period is considered as the foundation of the better future life and every incidence has influence on the further life. Disability is a major problem those effect the better life of children. While disability is discussed particularly in children, about a quarter of chronic childhood problems are neurological in origin. Cerebral palsy (CP) is caused by damage to or abnormalities inside the developing brain that disrupt the brain s ability to control movement and maintain posture and balance. The term cerebral refers to the brain; palsy refers to the loss or impairment of motor function [1]. In Cerebral palsy some conditions found in classics at different places like Pangulya, Mukatva, Jadatva, Ekanga Roga, Sarvanga Roga, Pakshaghata, Pakshavadha etc, under the group of Vatavyadhi [2]. Contributory factors are like inappropriate Ritu, Kshetra, Ambu
Impact factor: 0.3397/ICV: 4.10 109 and Bija [3], Dauhrida Avamanana [4], presence of Garbhopaghatkarbhava [5], incompatible Garbha Vriddhikarabhava [6] and improper following of Garbhini Paricharya [7]. Considering the signs and symptoms of CP, this disease seems very closer to the presentation of Vata Vyadhi. Basti is very helpful in pacifying Vata, further it is glorified that Basti Chikitsa as Ardha Chikitsa of Vata [8]. By these facts, Basti is most important among the Panchakarma in the treatment of CP. There are many types of Bsati. According to number Charak is described three types: Karma, Kala and yoga. This pattern of Basti includes the group of eight Basti, out of which five are Anuvasana and three are Niruha. The schedule is started with Anuvasana on the day one followed by three Niruha and three Anuvasana alternatively. Lastly, one Anuvasana is to be given [9]. Yoga Basti is indicated in Kaphanubandhi Vata Prakopa, Alpa bala and Vata Dosha vatiation [10]. No other Chikitsa has the capacity to pacify and regulate the force of Vata apart from Basti [11]. Same hypothesis was assumed for this clinical trial. Pakwashaya is the seat of Vata Dosha. Basti denotes Karma where the drugs administered through the rectal canal stay for certain period in the body. Then produce the coating of the Sneha in the body and draws out the waste substances from all over the body into the colon and eliminates them out of the body by producing movements in the colon resulting into pleasant (beneficial) effect. According to Charaka, Basti is the Karma in which, the medicine prepared according to classical references is administered through rectal rout and it reaches up to the Nabhi Pradesh, Kati, Parshwa, Kukshi (small intestine) churns the accumulated Dosha and Purisha, spreads the unctuousness (potency of drugs) all over the body and easily comes out along with the Purisha and Dosha (impurity) [12]. In Lehadhyaya chapter of Kashyapa Samhita, reference of such Lehana Yoga named Samvardhana Ghrita is promoting general growth, strength and intellect of children. This Ghrita is mentioned for smooth and rapid growth of child without interference of any disease for healthy child and improving or treating the conditions in Pangu (lame), Muka (dumb), Ashruti (deaf), Jada (idiot) [13]. This reveals the possible efficacy of Samvardhana Ghrita for improving the condition in CP or other similar conditions. MATERIALS AND METHOD Material Diagnosed patient of Cerebral palsy attending O.P.D. & I.P.D. of Kaumarbhritya Department, I.P.G.T. & R.A., Jamnagar were taken for the research work. Samvardhana Ghrita was collected from pharmacy of Gujarat ayurved university Jamnagar. Inclusion criteria:
Impact factor: 0.3397/ICV: 4.10 110 1. Age group - 1 year to 10 years of both sex. 2. Children with severe type of the disability (GMFCS Score upto level 5) were included in study. Exclusion criteria: 1. Children s age < 1 and > 10 years. 2. Children with major congenital disorders. 3. Children with other diseases ex. Juvenile diabetes, tuberculosis, acute infection etc. Method: Study Design: The randomized simple sampling method. LABORATORY INVESTIGATIONS: Blood : Hb, TC, DC, ESR, CRP (If needed) Urine : Routine and microscopic examinations. (If needed) Stool : Routine and microscopic examinations. (If needed) TRIAL OBJECTS: Drug : Samvardhana Ghrita Procedure : Udvartana, Abhyanga, Swedana and Yoga Basti STUDY DESIGN: Patients received Samvardhana Ghita for 62 day orally. Udvartana with Yava and Kulattha for 5 days, Abhyanga with Bala Taila + Nadi Sweda for 5 days and 8 days of Yoga Basti with 16 days of interval, Such 3 courses were repeated. Dose of Samvardhana Ghrita was determined by using reference of Sharngdhara Samhita [14]. (Table no.1) Dose of Basti Dravya is given as per the reference of Charaka Samhita [15] (Table no 2.) Doses for Aasthapana Basti. Anuvasana should be given ¼ of the quantity of Aasthapana Basti. Table 1 Age wise dose of Samvardhana Ghrita Age group Dose (Once / Day) 1 3 yrs. 2.5 gm. 4 7 yrs. 6 gm. 8 10 yrs. 9.5 gm. Sahapana Duration Follow up : Madhu : 62 days : 8 weeks
Impact factor: 0.3397/ICV: 4.10 111 Table no 2. Age wise dose of Aasthapana Basti Age in year Prasruta Tola Gms. 1yr 1/2 4 48 2yr 1 8 96 3 yr 1 ½ 12 144 4 yr 2 16 192 5 yr 2 ½ 20 240 6 yr 3 24 288 7 yr 3 ½ 28 336 8 yr 4 32 384 9 yr 4 ½ 36 432 10 yr 5 40 480 Basti schedule:- Yoga basti was administer as per the schedule that is A N A N A N A A ASSESSMENT COMPONENTS: A= Anuvasana Basti, N= Niruha (Asthapana) Basti Assessment criteria include Centers for diseases Control and prevention(cdc) grading for motor milestones, suitable scoring pattern was prepared for Fine Motor, Language and Personal and Social milestones, Ashworth Scale to assess spasticity, Muscle Power grading, Manual Ability Classification System (MACS) to assess the function of upper limb, Gross Motor Functions Classification System (GMFCS) and Activities of Daily Living score (ADL) was taken as assessment criteria to observe the effect of therapy. Table no 3. ASSESSMENT OF TOTAL EFFECT OF THERAPY: Complete Remission Marked Improvement Moderate Improvement 100% improvement of clinical signs and symptoms. More than 75% to 99% improvements of clinical signs and symptoms. More than 50% to 75% improvement of clinical signs and symptoms. Mild Improvement More than 25% to 50% improvement of clinical signs and symptoms. Improvement More than 10% to 25% improvement of clinical signs and symptoms. Unchanged 0 to 10% improvements of clinical signs and symptoms. Worsened Less than 0% worsened of clinical signs and symptoms. Statistical analysis was done by using paired t and student unpaired t test. Discussion Samvardhana Ghrita Samvardhana Ghrita is described in Lehadhyaya chapter of Kashyapa Samhita. It is mentioned for smooth and rapid growth of child without interference of any disease for healthy
Impact factor: 0.3397/ICV: 4.10 112 child and improving or treating the impaired conditions in those who are Pangu (lame), Muka (dumb), Ashruti (deaf) and Jada (idiot) [16]. Table no 4. Ingredients of Samvardhana Ghrita: No Ingredients Latin name Part used Qty 1. Khadira Acasia catechu Willd Heart wood 1/7 2. Prishniparni Pseudarthria viscida Desv Whole plant 1/7 3. Syandana Ougenia dalbergiodes Benth Stem Bark 1/7 4. Bala Sida cordifolia Linn Whole plant 1/7 5. Atibala Abutilon indicum Linn Whole plant 1/7 6. Kebuka Costus speciosus Smith Rhizome 1/7 7. Saindhav Sodium Chloride - 1/7 8. Kshira Milk - 1 9. Ghrita Ghee - ½ 10. Jala Water - 4 Pharmacodynemic action of Ingredients of Samvardhana Ghrita are mentioned in Dravya Guna Vigyaniyam, Charak and Susruta Samhita [17-19]. Table no 5. Pharmacodynemic actions of Ingredients of Samvardhana Ghrita: No. Ingredients Rasa Guna Virya Vipaka Karma 1. Khadira Tikta, Laghu, Ruksha Sheeta Katu Pachana Kashaya 2. Prishniparni Madhura, Tikta Laghu, snigdha Ushna Madhura Balya, Vatahara, 3. Syandana Kashaya Laghu, Ruksha Sheeta Katu Rasayana 4. Bala Madhura Snigdha Sheeta Madhura Balya, Rasayana 5. Atibala Madhura Snigdha Sheeta Madhura Balya, Rasayana 6. Kebuka Tikta Laghu, Ruksha Sheeta Katu Deepana, Pachana, 7. Saindhav Lavana Snigdha, Ushna, Tikshna Anushna Sheeta and Madhura Deepana, Pachana Sheeta 8. Kshira Madhura Mridu, Snigdha Sheeta Madhura Medhya, 9. Ghrita Madhura Snigdha, Mridu, Guru 10. Jala Madhura Laghu, Sukshma,Vishada Observations: Balya Sheeta Madhura Medhya, Balya, Rasayana, Sheeta Madhura Medhya, Balya, Rasayana Total 8 Patients were completed the present study. In the clinical study maximum number of (45%) of the Patients belonged to age group of 4-7years and 82% were males. Majority of them belonged to Hindu religion (82%),middle socio -economic status(73%),education not started
Impact factor: 0.3397/ICV: 4.10 113 (91%).In antenatal history of mother Hyperemesis gravidarum(45%),infection(9%)and hypertension(18%),trauma, antepartum hemorrhage, were (5-5%).maximum patients were delivered in hospital(82%), LSCS(27%), Forceps delivery(9%), Preterm(27%),normal Birth Low birth weight(18%),very low birth weight(18%),delayed cried after birth(55%),convulsion, pathological jaundice and fever ( 36%), meconium aspiration(27%), birth asphyxia, cord around neck, septicemia (9%). Hospitalization was required (36%),Resuscitation(55%) according to feeding pattern during neonatal period Breast fed (45%) and Breast + bottle feeding (65%).Spastic CP (82%),Hypotonic (18%), severe type of CP (64%) and moderate type(27%) (25%) and mild type (9%). The signs and symptoms reported included, developmental delay, feeding problem, language impairment(100-100%), vision problem, hearing problem and abnormal movements (9%) and mental retardation (36%),Spasticity, contractures were observed in 82%, 45%, patients respectively. Impaired co-ordination, impaired orientation, and poor head growth (Microcephal y) were found in 82%, 73%, and 45% patients, recurrent respiratory tract infection(18%), Bowel control Not Achieved (45%),Bladder control not achieved (55%), Feeding Difficulties and Excessive salivation (64%), Constipation (18%), Liquid(45%), semisolid(36%) and solid (18%), Proper immunization (100%), joint family(36%) and nuclear family(65%). Positive Family history(95% mothers age between 26-31 years(9%) and fathers belong to 29-36years(9%), Parental history Abortion (11%),Primiparity(89%),H/o Consanguinity (18%) use of anti epileptic drug (AED)(9%) and Muscle relaxant (18%), physiotherapy was taken by 36% of patients. EFFECT OF THERAPY ON ASSESSMENT CRITERIA Anthropometric measurement Patients treated with Samvardhana Ghrita and Yoga Basti, improvement was found in length (0.12%), weight (1.75%), Chest circumference (0.27) and Mid thigh circumference(0.35). 1.5 1 0.5 n=8 Percentage % Series 1 0 Length Weight Chest circumference Mid thigh circumference Figure 1. Effect of therapy on Anthropometric measurement
Impact factor: 0.3397/ICV: 4.10 114 Development milestone Patients treated with Samvardhana Ghrita and Yoga Basti, improvement was found in neck holding (8.33%), sitting (8.33%), standing (6.66%), Fine motor (7.7%) language (14.48%), personal and social milestones (17.29%) and gross motor classification system (GMFCS) (11.42%). 20.00% 18.00% 16.00% 14.00% 12.00% 10.00% 8.00% 6.00% 4.00% 2.00% 0.00% n=8 Series 1 Figure 2. Effect of therapy on Development milestone Probable mode of action: Most of the drugs in Samvardhana Ghrita are having Madhura, Tikta Rasa, Guru Guna, Shita Virya and Madhura Vipaka. As per available reference, drugs like Bala, Atibala, Mandukparni, Ghrita and Kshira is indicated for improving higher brain functions like Medha (Intellectual), Rasayana etc. Indication of Sanvardhana Ghrita in Vaka, Medha, Smruti, Buddhi enhancement, shows its efficacy to target motor, sensory and higher functions. Main causation of Vata is observed and with the use of this Ghrita probable correction takes places at vitiated Vata level and thereby improving in these parameters and clinical signs and symptoms of Cerebral Palsy. Medhya property of Samvardhana Ghrita has also improved Personal & Social milestone in this study.so indication of Samvardhana Ghrita in Vaka, Medha, Smruti, Buddhi enhancement, shows its efficacy to target motor, sensory and higher functions. Udvartana with rukshana effect removes vitiated kapha and ama dosha, clears the orifices of hair follicles and improves lymphatic and blood circulation which is helpful to absorption the drugs to the target site [20]. Abhyanga nourishes the Dhatu and increases their strength. It corrects and prevents disorders caused by affliction of Vata. It helps in the promotion and regulation of the proper functioning of Vata [21]. Swedana relieves stiffness, heaviness and coldness of the body [22].This study shown increased muscle bulk, power and diminished muscle tone through Abhyanga procedure and
Impact factor: 0.3397/ICV: 4.10 115 decreased stiffness of body by Swedana Karma. Improvement in muscle bulk, power, tone and developmental milestones with Yoga Basti included, Anuvasana Basti is more beneficial particularly in affliction of Vata [23]. It has Vata Shamana, Balya and Dhatu Poshana and Asthapana Basti (Madhutailika) has Dosha Nirharana properties which removes morbid dosha and to gain strength and complexion [24]. Basti dravya prepared by various drugs like madhu, taila influences the normal bacteria flora of the colon.so vitamin B12 synthesis is increases, which has an important role in the repair and regeneration of nerves [25]. Thus, Udvartana, Abhyanga, Swedana and Yoga Basti act on sharira and manas brumhana. CONCLUSION Samvardhana Ghrita and Yoga Basti is effective in relieving the signs and symptoms and reducing the disability in children with CP.This study, shown result in improving the disease condition. More outcomes is observed in improving the milestones Growth and Motor components, language, personal and social leads to more effectual protocol of combined treatment (Internal medication as well as Panchakarma procedures). ACKNOWLEDGEMENT Author is thankful to his guide and co-guides for their encouragement towards research work. REFERENCES 1. http://www.ninds.nih.gov/disorders/cerebral_palsy/detail_cerebral_palsy.htm July 2, 2015 2. Agnivesha, Charaka, Drihabala, Charaka Samhita,Sutrasthana, Maharogaadhyaya, 20/11, edited by Dr. Brahmanand Tripathi, Chaukhambha Surbharti Prakashana, Varanasi, 2012; p. 390. 3. Devodas Dhanvantari,Sushruta, Susruta Samhita, Sharira Sthana Shukrashonitashuddhisharira adhyaya,2/33,edited by Ambika Dutta Shastri, Chaukhambha Sanskrit Sansthana,Varanasi,2009, p. 19. 4. Agnivesha, Charaka, Drihabala, Charaka Samhita,Sharirasthana, Mahtigharbhavkrantiadhyaya, 4/15, Chaukhambha Surbharti Prakashana, Varanasi, 2012, p. 881. 5. Agnivesha, Charaka, Drihabala, Charaka Samhita, Sharirasthana, Mahtigharbhavkrantiadhyaya, 4/18, Chaukhambha Surbharti Prakashana, Varanasi, 2012, p. 884.
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