INTRODUCTION- Women are the backbone of the family and society. Due to environmental influence, lifestyle changes, diet habits women are facing stress and many gynecological problems. Uterine fibroid or leiomyoma is one of them. Uterine fibroids are most common benign tumor in women. In India, the prevalence of fibroid is reported to be 37.65 % in rural population and 24 % in urban population. The prevalence of fibroids was significantly lower in the younger age group i.e 25-35 years of age (6.7%) as compared to the group with females of 36-45 years of age (33.3%)1. According to National Family Health Survey (NFHS) data, 3% of women aged 15-49 years in India have undergone hysterectomy. Less than 0.1% of all uterine fibroids are malignant. Possible risk factors of uterine fibroid are early menarche, nulliparity, obesity, high fat diet, BMI >30 in reproductive age ,having non vegetarian diet, lack of exercise, use of estrogen containing medication, hypertensive patients. The real cause of uterine fibroid is still unknown yet there is considerable evidence that estrogen and progesterone proliferate the tumor growth2 Uterine fibroid can be correlated with Garbhashayagata Arbuda. According to Acharya Sushruta clinical features of Arbuda are : * Mamsamabhi Pradushya - It is composed essentially of muscle tissue with variable amount of fibrous connective tissue * Vrutum - Round shaped * Sthirum - Fixed to the surrounding tissue * Manda Rujam - Less painful * Mahanatam - Large in size * Analpamulam - Deep rooted due to infiltration to the surrounding tissues. * Chira Vrudhhi - Chronic in nature(takes many years to grow) * Apakam - No suppuration until it is not infected (S.S.NI.11/17-18)3 There are 6 types of Arbuda according to Acharya Sushruta, namely : 1. Vatarbuda 2. Pitarbuda 3. Kapharbuda 4. Raktajarbuda 5. Mamsajarbuda 6. Medojarbuda 

 Uterine myomas have been classified according to their general uterine position: 1. Intramural/Interstitial Fibroid And 2. Subserosal/Subperitoneal Fibroid 3. Submucous Fibroid 4. Cervical Fibroid Symptoms of uterine fibroid are menorrhagia,metrorragia,dysmenorrhea,pelvic pain pressure symptoms etc or it may be asymptomatic. Vamana(medicated emesis) and Uttar Basti are selected as the treatment procedure in this study so that it will help to clean the srotas. And once the body is detoxified, one can start oral medicines which will help to support the normal functioning of the uterus. NEED OF STUDY:- In modern science uterine fibroid is treated by surgery or hormonal therapy and include many drugs like GnRH analogs, progesterone antagonists, etc. But they have so many side effects similar to the symptoms of menopause like hypoestrogenic state, hirsutism, depression, etc. It is one of the main leading cause of hysterectomy. In order to avoid surgery to a possible extent, seeking Ayurvedic or any other alternative treatment is opted. Hence this study tends to provide an alternative and effective Ayurvedic treatment protocol for the management of same. In Ayurveda, there is a large scope of research to find out safe and cost effective remedies for the management of garbhashaya gata arbuda (uterine fibroid). Review of Previous Research works: S.n. title author year 1 Ayurvedic investigation in management of uterine fibroid Kamini dhiman 2014 2 Effect of palashk kakar on uterine fibroid Meshram manjusha 2014 3 A clinical evaluation of gomutra haitaki on uterine fibroid Yogesh l.manani l.p.dei shilpa b donga hetal p baraiya 2015 4 Role of jalkumbh in uterine fibroid Seema murthy,siddaram arawatti,pankaj rai,debases biswal,mohapatra nibedita 2015 5 Uterine fibroid-a single case Dharita pateland,dr.hemant 2007

  study toshikane 6 Pharmacognostical and pharmaceutical evalution of hemkanda ghruta-an ayurvedic formulation Dr.yogesh manani,prof.lp dei,dr.rahul singadiya 2017 7 Management of garbhashaya arbuda-a case study Kowsalya RG,swetha naik AD,padmasarita k,Ramesh M 2017 8 Uterine fibroid in ayurvedic perspective Usha DT,sowmaya MN 2018 9 A case study-regression of uterine fibroid through holistic management of Ayurveda Mayuri shingnapurkar,UR shekhar namburi, MN suryawanshi 2018 10 Management of uterine fibroidin Ayurveda perspective Shruti g math,padmasaritha K,Ramesh M - 11 Role of virechana karma in the management of uterine fibroidalong with metro rrhagia MS sanjeewane perera,prof.LPdesh 2-018 RATIONALITY OF SELECTION OF TRIAL DRUG:- Due to multi-factorial etiology and involvement of dosha-dushya sammoorchhana at the cellular level, shodhana is an essential part of Ayurvedic management of uterine fibroid followed by shaman. So, in the present study, an attempt has been made to compare the combined effect of Vamana Karma and uttar Basti along with kanchnar guggulu(with anupana of khadir sara kasayam) Vamana : In garbhashaya gata arbuda, there is dominency of kapha and meda,4,5 therefore vamana karma is appropriate shodhan karma for it. Aggravated kapha dosha is expelled out through the vamana karma.7   

Uttara basti-

The vitiation of vata is considered as causative factor for the beginning of Mamsja arbuda. Basti is the best treatment to pacify vata as "Basti vatharanam shreshtham". Among the three types of basti uttar basti has some special quality hence it is nominated as uttar i.e. shreshtha. Here the place origin of arbuda is uterus so uttar basti is chosen as the treatment modality as it well help to target the root by administering the medicine directly into the uterus. Kanchnara Guggulu: Kanchnar guggulu is indicated in the management of gandamala, apachi, arbuda, granthi, vrana, gulm, kushtha, bhagandar according to Bhavprakash Acharya.6 In this preparation maximum drugs have deepana, shothaghna, medohar effect as manda jatharagni is responsible for manda mamsadhatvagni because of which vitiation of mamsa, meda and rakta occur. Khadir Sara Kashaya: Khadir is an effective herb promotes blood clotting and control bleeding disorders. According to Bhavaprakash properties of khadir are sheetvirya, tikta kashaya rasa ,katu vipaka, kapha pitta shamak, shothahar, medoghna. Because of these properties it is taken as anupana in management of Arbuda7 Research Question: Is there any difference in the efficacy of Vamana Karma and Uttar Basti along with kanchnar guggulu (with khadir sara anupana) in the management of garbhashaya gata arbuda w.s.r. to uterine fibroid. Hypothesis: • NULL HYPOTHESIS [H0]: There is no difference in the efficacy of Vamana karma and Uttar Basti along with kanchnar guggulu (with anupana of khadir sara) in the management of garbhashaya gata arbuda w.s.r to uterine fibroid. • ALTERNATIVE HYPOTHESIS [H1]: There is difference in the efficacy of Vamana karma and uttar Basti along with kanchnar guggulu(with anupana of khadir sara) in the management of garbhashaya gata arbuda w.s.r to uterine fibroid. 

  Aim-To evaluate the role of Vamana karma and Uttara Basti along with Kanchnara Guggulu in the management of garbhashaya gata arbuda w.s.r. to uterine fibroid. Objectives: Primary objective- To evaluate the role of vaman karma and uttara basti along with kanchnara gugglu in the changes in size ,volume and consistency of uterine fibroid. Secondary objective- To evaluate the role of vaman karma and uttara basti along with kanchnaar gugglu in management of menstrual irregularities and associated symptoms such as pain and pressure etc. MATERIALS AND METHODS: Literary Review: Literary references will be collected from Ayurveda i.e. classics, commentaries, modern literature, research journals available in institute library, online portals like PubMed Central, AYUSH Research Portal, Google scholar and analyzed to frame conceptual work. Clinical Study: • Selection of the patients: Patients will be selected from O.P.D. and I.P.D. of Prasuti tantra and Stri-roga as per criteria. Written informed consent will be taken from each patient before starting the trial. • Study type A randomized open label comparative clinical study. • Timing- Prospective • Method of generating randomization sequence - Computer generated. • Method of allocation concealment - SNOSE (Sequentially-Numbered, Opaque, Sealed Envelopes). • Blinding/ masking - Open labeled. ï‚· Primary outcome – To assess the effect of treatment on size, shape and volume of the uterine fibroid. ï‚· Secondary outcome – Changes in menstrual parameters and associated symptoms such as pain and pressure etc 

• Site of study- O.P.D. and I.P.D. level 10 • Number of Groups- Two groups • Sample Size- 40 patients (20 patients in each group). • Primary purpose –Treatment. • End Point – Efficacy and Safety INCLUSION CRITERIA: • Female patients of age group between 21 – 50 years ( married). • Having fibroid of up to5 cm size (confirmed by USG) • Single or Multiple uterine fibroids . EXCLUSION CRITERIA: • Uterine fibroid (more than 5 c.m.) • Pregnant women. • Women having hemoglobin less than 7 gm/dl • Patients using IUCDs. • Women of age less than 21 years and above 50 years. • Patients with chronic systemic illness. • Patients with positive Sexually transmitted diseases (STDs), Human Immunodeficiency Virus HIV, Hepatitis B Surface Antigen (HbsAg). • Patients who are contraindicated for Uttar Basti and Vamana Karma. WITHDRAWAL CRITERIA: • During the course of clinical trial, if any serious condition or any serious adverse effects develops which require urgent treatment. • If the patient herself wants to withdraw from clinical trial. • Non-compliance of patient. LABORATORY INVESTIGATIONS: For the purpose of assessing the general condition of patients and exclusion of other pathogenesis the following investigations will be performed. BEFORE TREATMENT: Blood and serological tests- ï‚· CBC (Complete Blood Count) ï‚· Lipid Profile  

ï‚· ESR (Erythrocyte Sedimentation Rate) 11 ï‚· VDRL (Venereal Disease Research Laboratory) ï‚· HIV (Human Immunodeficiency Virus) ï‚· HBsAg (Hepatitis B Surface Antigen) ï‚· Liver function test (LFT) • Renal function test (RFT) • RBS (Random blood sugar) • S.electrolytes Urine Test – • Routine & Microscopic. • Urine pregnancy test[if needed] USG- Uterus & adnexa Hormonal test- on • Serum estrogen and serum progesterone AFTER TREATMENT • USG - Uterus &Adnexa. • Lipid profile • LFT • RFT • CBC • Serum electrolytes • Serum estrogen and serum progestrone Trial Drugs Group A – Vamana karma followed by kanchnara guggulu with khadirsara kashaya as anupana Group B – Uttara Basti followed by kanchnara guggulu with khadirsara kashaya as anupana Drugs for Vamana Karma – Sr. No. Karma Drug Name Deepan 1. and Pachan Chavya Panchakola Churna Botanical Name Piper retrofractum Family Piperaceae Part Used Fruit Vahl. 

 Chitrak Plumbago zeylanica Linn. Plumbaginaceae Root Shunthi Zingiber officinalis Rosc. Zingiberaceae Root Pippali Piper longum Linn. Piperaceae Fruit Pippali mool Piper longum Linn. Piperaceae Root 2. Snehapana Go-Ghrita 3. Vamana Karma Vamaka Yoga Madanphala Randia spinosa Poir. Rubiaceae Fruit Vacha Acorus calamus Linn. Araceae Root Madhuyashti Glycyrrhiza glabra Linn. Leguminosae Root/Stem Saindhava Sodium chloride Drugs for Uttara Basti – Sr. No. Karma Drug Name Botanical Name Family Part Used 1. Purvakarma – Mridu Shodhan Basti Madhu - - - Saindhav Lavana Rock salt - - Dashmoola taila - - - Shatapushpa kalka Anetum grauveolens Umbelliferae Fruit Kwath Dravya Bilva Aegle marmelos Rutaceae Roots Agnimantha Premna mucronata Verbenaceae Roots Shyonaka Oroxylum indicum Bignoniaceae Roots Patala Sterospermum sauveolens Bignoniaceae Roots Gambhari Gmelina Verbenaceae Roots 

 arborea Brihati solanum Solanaceae Roots Kantakari Solanum xanthocarpum Solanaceae Roots Gokshura Tribulus terrestris Zygophyllaceae Roots Shalaparni Desmodium gangeticum Fabaceae Roots Prishnaparni Uraria picta Roots 3. Pradhan Karma – Uttar Basti Kshar Tail8 Mulaka Raphanus sativus Crucefereae Root Svarjika Kshara Yava Kshara Hordeum vulgare Gaminae Panchanga Vida lavana Salt Romaka lavana Salt Saindava lavana Salt Sauvarchal lavana Salt Hingu Ferula narthex Apiaceae Resin Shigru Morniga oleifera Moringaceae Bark Mahaushadha Zingiber officinalis Zingiberaceae Root Devadaru Cedrus deodara Pinaceae Root Vacha Acorus calamus Acoraceae Root Kushtha Saussurea lappa Asteraceae Root Rasanjana Berberis aristata berbiridaceae Root Shatapushpa Anetum sowa Apiaceae Granthika (Pippali) Piper longum Piperaceae Fruit Musta Cyperus rotundus Cyperaceae Root Kadali Musa paradisiaca Musaceae Stem Beejapoora Citrus medica L. Rutaceae Fruit Madhu shukta    

Drug for oral medicine: ï‚· Kanchanar Guggulu with Khadir sara kashaya Sr. No. Drug Name Botanical Name 1. Kanchanara Bauhinia variegata Family Fabaceae Part Used 2. Tree bark Sunthi Zinziber officinalis Zingiberaceae 3. Dried root Maricha Piper nigrum Piperaceae 4. Dried fruit Pippali Piper longum Piperaceae 5. Dried fruit Haritaki Terminalia chebula 6. Combretaceae Dried fruit Amalaki Vibhitaki Embilica officinalis Phyllanthaceae Dried fruit 7. Terminalia belllirica Combretaceae Dried fruit Varuna 8. Crataeva nurvala Capparaceae 9. Patraka Cinnamomum tarmala Lauraceae Bark Leaves 10. Ela Ellettaria cardamomum Zingiberaceae 11. Twaka Cinnamomum zeylanicum Lauraceae Fruit Bark 12. Guggulu Commiphora mukul Burseraceae 13. Khadir Resin Acacia catechu Fabaceae WORK-PLAN: Grouping- Sara 40 Patients selected according to inclusion criteria will be devided randomly into two groups of 20 patients each. Procedure will be started after cessation of menses Group A Shodhan (as per SOP of panchakarma dept.) Deepan-Pachan – With Panchkola 5 gm(as per koshtha) Twice for 5 days 10 min before food Group B churna Poorva Karma Mridu Shodhan Basti for 3 days 

  Poorva Karma Snehapana – With murchhita go-ghrita empty stomach for 5-7 days Vishram divas 1 day(kapha utkleshakar ahara) Sarvanga Abhyanga and Swedan (Before every basti) Sarvanga Abhyanga with dashmoola taila and Swedan with dashamoola quath 2 days Pradhan Karma Vamana with Vamaka Yoga (1 day) Pradhan Karma Uttara Basti with Kshar tail 5ml for 6 days. (3 Uttar bastis followed by 3 days gap then again 3 Uttar bastis followed by 3 days gap - for 1 cycle.)(as per SOP of PTSR dept.) Paschat Karma ï‚· Dhoompana (Just after vamana karma) ï‚· Samsarjana Karma as per vegiki shuddhi Paschat Karma Sthanik swedan (Just after uttara basti) Total No. of Days 15 days 15 days Shamana Kanchnara guggulu9 orally 1 gm with Khadirsara Kashaya 40 ml as anupana once in early morning empty stomach at 7 am for 60 days after completion of shodhan chikitsa Kanchnara guggulu orally 1 gm with Khadirsara Kashaya 40 ml as anupana once in early morning empty stomach at 7 am for 60 days after completion of shodhan chikitsa DURATION FOR CLINICAL TRIAL: • 75 days for both the groups. FOLLOW UP STUDY: • During trial - After cessation of menses. • After completion of the trial case will be followed after one month.   

Criteria of assessment -

All the patients registered for the present trial will be assessed on the basis of following parameters.:- PARAMETERS – Quantity of Menstrual Bleeding  Duration of Menstrual Bleeding Interval between two Menstrual Cycle  Pain during Menses and during the days other than menses. Pressure symptoms Changes in Size of fibroid  STATISTICAL ANALYSIS: The observations and result will be analyzed and presented on the basis of respective and applicable statistical tests. ETHICAL CONSIDERATIONS: This study will be conducted according to the prevalent standards of Good Clinical Practices. This protocol and any amendments will be submitted to Institutional Ethic Committee (IEC) for approval of the study conduct. Study will be registered in CTRI (Clinical Trial Registry of India) before starting the trial. ANNEXURE 1.1 Pictorial blood loss assessment chart (PBLAC) To assess the amount of bleeding Pictorial blood loss assessment chart will be used. Each row represents a day of the month count the number of sanitary pads and/or tampons use each day (24 hour period). Calculate a score for each day and then add up the score at the end of the month. Bleeding between periods-if you also experienced bleeding between periods that required sanitary protection, please record this on the relevant days. Clots – if pass clots, please indicate this on the relevant days and the approximate size (i.e. closer to an Australian 5 cent or 50 cent piece). Flooding – if experience any episodes of ‘flooding/overflowing/staining of clothing/underwear please indicate the number of episodes on the relevant days. Double protection- if have used both a pad and tampon simultaneously 

 and both sanitary items were stained with blood don’t forget to include both sanitary items on the PBLAC. PBAC SCORING SYSTEM Pads: 1 point For each lightly stained pad 5 point For each moderately stained pad 20 point For each completely saturated pad. Tampons: 1 point For each lightly stained tampon 5 point For each moderately stained tampon 10 point For each completely stained tampon Clots/ flooding: 1 point For each small clot ( Australian 5 cent coin ) 5 point For each large clot ( Australian 50 cent coin ) 10 point For each episode of flooding. • Grading of assessment criteria- S. No. Assessment Criteria Grade 0 Grade 1 Grade 2 Grade 3 1. Interval between two Menstrual Cycle 25-28 Days 20-24 Days 15-19 Days Less Than 15 Days 2. Duration of Menstrual Bleeding Less Than 5 6-7days 8-9days More Than 9 Day 3. Amount of flow Scanty Moderate Heavy Without Clots Heavy With Clots 4. Quantity of Menstrual Bleeding Less than 15 Pads /Cycle 15-20 Pads/Cycle 20-25 Pads/Cycle More than 25 Pads/Cycle 5. Pain during Menses No Pain Mild Moderate Severe 6. Pressure symptoms No Passes hard Passes hard Need of 

constipation 18 &soft stool often &soft stool regularly but no need laxative 7 Size of fibroid Up to 1cm laxative >1 to 2cm Visual Analogue Scale Score Zero Assessment >2 to 3cm >3 to 4cm [>4cm to5 cm in grade 4] First Assessment Second Assessment Follow Up Overall effect of therapy 1.Mild relief [up to 25% relief] 2.Moderate relief[>25% TO 50 %relief] 3.Significant relief[>50%to 75%relief] 4. Excellent relief[>75% to100%relief] Visual Analogue Scale : 

  References : 1 https//www.ijrcog.org 2 hira lal konar Dc data .text book of gynaecology including benign lesion of the uterus chapter 20 page no 224 225 3 Sushurut samhita commentary dalhan su.ni.aadhya 11 ,17-18 4 Susshurut samhita nidansthan 11/21 5 A.s.u.34/15 a.h.u.29/15 6 Sharangdhara samhita madhyamkhanda adhya 7/95-100 7 Bhava prakasha nighantu vatadi varga verse 30-32 8 Sharangdhar samhita madhyam khanda sloka 174-177 9 Bhaishajya ratnavali galganda roga chikitsa 44/64-69