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CTRI Number  CTRI/2016/04/006793 [Registered on: 04/04/2016] Trial Registered Retrospectively
Last Modified On: 26/04/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Ovarian Cyst by Ayurveda 
Scientific Title of Study   A CLINICAL STUDY ON BEEJAKOSHA GRANTHI W. S. R. TO OVARIAN CYST AND ITS MANAGEMENT WITH VIRECHANA AND KANCHANAAR GUGGULU 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Vihariya 
Designation  Ms second year 
Affiliation  Ipgt and Ra Jamnagar 
Address  Ms scholar 2nd year department of stree roga and prasutitantra 5th floor ipgt and ra jamnagar gujarat india 361008
Ipgt and Ra Gujarat Ayurveda university jamnagar gujarat 361008 india
Jamnagar
GUJARAT
361008
India 
Phone  9510705281  
Fax    
Email  poojavihariya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr s b donga 
Designation  asso prof of srpt dept 
Affiliation  ipgt and ra 
Address  Associated prof srpt dept ipgt and ra jamnagar GUJARAT 361008 department of streerog evam prasooti tantra 5th floor ipgt and ra gujarat ayurveda university jamnagar GUJARAT 361008 India
Associated prof srpt dept ipgt and ra jamnagar GUJARAT 361008 department of streerog evam prasooti tantra 5th floor ipgt and ra gujarat ayurveda university jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9825646796  
Fax    
Email  drshilpadonga@yahoo.com  
 
Details of Contact Person
Public Query  
Name  dr l p dei 
Designation  prof and HOD of srpt dept 
Affiliation  ipgt and ra 
Address  prof and HOD srpt dept ipgt and ra jamnagar GUJARAT 361008 india department of streerog evam prasooti tantra 5th floor ipgt and ra gujarat ayurveda university jamnagar GUJARAT 361008 India
department of streerog evam prasooti tantra 5th floor ipgt and ra gujarat ayurveda university jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9228198366  
Fax    
Email  deilaxmipriya@yahoo.com  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 
 
Primary Sponsor  
Name  INSTITUTE FOR POST GRADUATION TEACHING AND RESEARCH IN AYURVEDA 
Address  INSTITUTE FOR POST GRADUATION TEACHING AND RESEARCH IN AYURVEDA OPP. CITY B POLICE STATION PN MARG JAMNAGAR 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nill  nill 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr pooja vihariya  ipgt and ra jamnagar department of srpt  department of srpt ipgt and ra jamnagar gujarat ayurveda university jamnagar gujarat india 361008
Jamnagar
GUJARAT 		 9510705281

poojavihariya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institute for postgraduation teaching and research in ayurveda INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with ovarian cyst,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group a virechana karma follwed by shamana yoga group b shamana yoga only  group a VIRECHANA KARMA Virechana Karma followed by Shamana Chikitsa Trivritadi Yoga Virechana will be administered in patients of group “A”. in group a shamana yoga will be applied without virechaan karma Procedure Drug & Dose Duration Deepana & Pachana -Trikatu Choorna-2gm/3times a day with warm water. for 3 Days. Snehapana with Go-Ghrita (as per Koshtha and Agni) for 3-7 Days Abhyanga and Swedana with Bala Taila for 3 Days Virechana Karma (Virechana Yoga -Ch. Chi 7/44 ) • Triphala 4 part(100gm) • Trivrit 2 part (50gm) • Danti 1 part(25gm) 1 Day Sansarjana Karma Diet (as per Shuddhi) 3-7 Days shamana yoga Kanchanar Guggulu - 3 gram in divided dose (Vati form) before meal 2 times Anupana-Munditaka Kwath-50 ml in divided dose 2 times  
Comparator Agent  group b   direct shamana yoga will be applied to the patients kanchanar guggulu in divided dose 3 gm per day in vati 2 timesform with anupana of munditaka kwatha 50 ml in divided dose 2 times 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  • Patients age group from 18 to 55years.
• Patients having cyst size ≤ 5 cm as per USG report (persist at list for 2 consecutive cycles.
• Single or multiple cysts/unilateral or bilateral /unilocular/ multilocular ovarian cyst.
• Patients either asymptomatic or having clinical signs and symptoms of ovarian cyst.

 
 
ExclusionCriteria 
Details  • Patient below the age of 18 years and above the age of 55years.
• Patient having cyst size > 5 cm as per USG report
• Pregnant women with cyst.
• Women with Hob < 7 gm%
• Tubo-ovarian mass, Dermoid cyst and malignant tumours and fibroid.
• Patient with uncontrolled Hypertension, Tuberculosis, DM and any other severe systemic disease
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the effect of Shamana Yoga and procedure (Virechana Karma) on ovarian cyst and to compare their efficacy (Based on TVS/TAS Colour Doppler USG)
2.reducing in size,volume and vascularity of ovarian cyst based on tvs
3.to evaluate the symptms of ovarin cyst bt and at value of them. 		 1.To evaluate the effect of Shamana Yoga and procedure (Virechana Karma) on ovarian cyst and to compare their efficacy
2.reducing in size,volume and vascularity of ovarian cyst based on tvs
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect on menstrual abnormalities, Dysmenorrhoea, etc. if any.  60 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/02/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   no 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Ovarian cyst is most common benign neoplasm, found in approximately 20 to 40% women of reproductive age group. Ovarian cysts are classified according to their position within the ovary.

·         FUNCTIONAL CYSTS-It is a normal cyst which forms during ovulation and disappear in two or three menstrual cycle. It is rarely seen in menopausal woman.

·         POLYCYSTIC OVARY-It makes the ovaries thicken and enlarge which make fertility problems.

·         CHOCOLATE CYST (endometriosis)-The tissue of endometrium grows in other areas outside the uterus in stomach. These are thick and brown blood in colour so called chocolate cyst.

·         DERMOID CYST-Cyst which are filled with hair, skin, teeth etc.

·         CYSTOEDENOMA-cysts which developed from cells of the outer side of the ovaries.

                          Though many women are not aware of them but Majority women with cysts are asymptomatic but in some women it shows many symptoms like,

 

 

SYMTOMS:-

·         Dysmenorrhoea

·         Irregular menses

·         Bleeding between periods

·         Dypareuria

·         Breast tenderness

·         Bowel difficulties

·         Lower backache and Leg  pain

Nausea and vomiting
 Ovarian cancer is 2nd most common of genital cancers and accounts for 10-15% of all gynaecological cancers in developing countries including Iindia

treatment for ovarian cyst

group a- deepana pachana with trikatu churna for 3 days snehapaana for 3 to 7 days abhyanga and swedana for 3 days virechana with triphala kwath then sansarjana krama for 3 to 7 days then shamana yoga will be applied of kanchanar guggulu  3 gm in vati form in divided dose per day and munditaka kwatha 50 ml in diveded dose per day for 60 days.
group b-shamana yoga kanchanar guggulu  3 gm in vati form in divided dose per day and munditaka kwatha 50 ml in diveded dose per day for 60 days.

 
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