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CTRI Number  CTRI/2019/03/018099 [Registered on: 15/03/2019] Trial Registered Prospectively
Last Modified On: 14/03/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Garbhashaya arbuda with Virechana,Lekhana Basti and oral therapy 
Scientific Title of Study   EFFECT OF VIRECHANA, LEKHANA BASTI AND ORAL THERAPY IN THE MANAGEMENT OF GARBHASHAYA ARBUDA W.S.R. TO UTERINE FIBROID -AN OPEN LABELLED SINGLE ARM CLINICAL TRIAL  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gauravkumar Balat 
Designation  Ph D 1st year 
Affiliation  IPGT and RA 
Address  ROOM NO - 24,PG BOYS HOSTEL, IPGT & RA, GUJARAT AYURVEDA UNIVERSITY,361001
5TH FLOOR, PRASOOTI TANTRA AND STREE ROGA DEPARTMENT, IPGT & RA, GUJARAT AYURVED UNIVERSITY,361001
Jamnagar
GUJARAT
361001
India 
Phone  9727528494  
Fax  9727528494  
Email  balatgaurav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PROF L P DEI 
Designation  PROF AND HOD OF PTSR DEPT AND DEAN IPGT AND RA 
Affiliation  IPGT AND RA 
Address  PROF. AND HOD OF PRASOOTI TANTRA AND STREE ROGA DEPARTMENT. 5TH FLOOR,IPGT AND RA,GUJARAT AYURVED UNIVERSITY,JAMNAGAR GUJARAT 361008 India
PROF. AND HOD OF PRASOOTI TANTRA AND STREE ROGA DEPARTMENT. 5TH FLOOR,IPGT AND RA,GUJARAT AYURVED UNIVERSITY,JAMNAGAR GUJARAT 361008 India
Jamnagar
GUJARAT
361001
India 
Phone  9228198366  
Fax  9228198366  
Email  deilaxmipriya@yahoo.com  
 
Details of Contact Person
Public Query  
Name  PROF L P DEI 
Designation  PROF AND HOD OF PTSR DEPT AND DEAN IPGT AND RA 
Affiliation  IPGT AND RA 
Address  PROF. AND HOD OF PRASOOTI TANTRA AND STREE ROGA DEPARTMENT,5TH FLOOR,IPGT AND RA, Jamnagar GUJARAT 361008 India
PROF. AND HOD OF PRASOOTI TANTRA AND STREE ROGA DEPARTMENT,5TH FLOOR,IPGT AND RA, Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361001
India 
Phone  9228198366  
Fax  9228198366  
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,GUJART AYURVED UNIVERSITY,OPP. CITY B POLICE STATION PN MARG JAMNAGAR,GUJARAT,361001 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR GAURAVKUMAR R BALAT  IPGT AND RA  ROOM NO- 24,PG BOYS HOSTEL,GUJARAT AYURVEDA UNIVERSITY,JAMNAGAR,GUJARAT,361001
Jamnagar
GUJARAT 		 9727528494
9727528494
balatgaurav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  patient with Garbhashaya arbuda uterine fibroid 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Single Group  Enrolled patients fulfilling the criteria, consists of minimum 60 patients with uterine fibroid (Single group) will be given below total duration of treatments for four months. 1st month – Virechana karma, 2nd month – Oral therapy with varunadi kwatha 50ml per day and Lekhana Basti 345ml per day for 16 days, 3rd month – Oral therapy with varunadi kwatha 50ml per day 4th month – Oral therapy with varunadi kwatha 50ml per day 5th month – follow up  
 
Inclusion Criteria  
Age From  20.00 Day(s)
Age To  50.00 Day(s)
Gender  Female 
Details  1.Both married and unmarried patient Age group between 20year TO 50years.
2.Patients having fibroid size 5 cm and < 5cm as per USG report
3.Single or multiple fibroids
4.The patient either asymptomatic or having clinical signs and symptoms of uterine fibroid.
5.Women with Hb > 7 gm%
6.Patient are suitable (Yogya) for Basti and Virechana
 
 
ExclusionCriteria 
Details  1.Patient <20 years and >50 years
2.Patient having fibroid size more than 5 cm as per USG report
3.Pregnant women with fibroid
4.Women with Hb < 7 gm%
5.Ovarian tumour, Tubo-ovarian mass and malignant tumours along with fibroid.
6.Patient with uncontrolled hypertension, tuberculosis, Diabetes Mellites and any other severe systemic disease.
7.Patients are not suitable (Yogya) for Basti and Virechana
8.Patients not willing to do Virechana and Basti
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To explore, correlate and review of uterine Fibroid with Grabhashaya Arbuda in Ayurvedic parlance.
To develop a standard Ayurvedic treatment protocol for management of Grabhashaya Arbuda (Uterine fibroid)
 		 Virechana,lekhana basti 16 days 1 cycle,varunadi kwatha for 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate & establish the efficacy of treatment protocol i.e Virechana Karma, Lekhana Basti and Oral therapy in the management of uterine fibroid(Garbhashaya Arbuda).  Virechana,lekhana basti 16 days 1 cycle,varunadi kwatha for 3 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   18/03/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Non yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Uterine fibroid, a noncancerous growth of the uterus also known as fibromyoma, leiomyoma or myoma,1, 2 that often appear during childbearing age most probably between 35-45 years in nulliparous or in those having one child infertility of female. It is the most common growth of the female genital tract.

The aetiology, classification, pathogenesis, and management of Garanthi/Arbuda are discussed in detail in the Ayurveda texts. Mamsa Granthi/Arbuda (uterine fibroid) is a Bahu Doshjanya vyadhi which involve the AstamaAshaya (Grabhashya) and deeper Dhatus (mamsa dhatu and Artav) in the body. Considering all these points this study has been planned and included the treatment protocol i.e. Virechana, Lekhana Basti and oral therapy. Hence, the present clinical study; i.e. to evaluate the effect of Virechana karma, Lekhana Basti with Lekhaniya Maha kashaya and orally Varunadi Kwath on uterine fibroid.

 
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