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CTRI Number  CTRI/2024/11/077505 [Registered on: 29/11/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   TO SEE THE EFFECT OF KSHARA GUDIKA ORALLY AND PANCHATIKTA GHRITA UTTARBASTI PROCEDURE IN THE MANAGEMENT OF GARBHASYA ARBUDA W.S.R UTERINE FIBROID 
Scientific Title of Study   A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KSHARA GUDIKA AND PANCHATIKTA GHRITA UTTARBASTI IN THE MANAGEMENT OF GARBHASYA ARBUDA W.S.R UTERINE FIBROID 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR PINKI 
Designation  MS SCHOLAR PRASUTI EVAM STREE ROGA 
Affiliation  INSTITUTE FOR AYURVED STUDIES AND RESEARCH  
Address  OPD NO 15 DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA INSTITUTE FOR AYURVED STUDIES AND RESEARCH UMRI ROAD SECTOR-8 KURUKSHETRA
UMRI ROAD SECTOR 8 KURUKSHETRA
Kurukshetra
HARYANA
136118
India 
Phone  7904001008  
Fax    
Email  pinkisheoran1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SUNITI TANWAR 
Designation  ASSOCIATE PROFESSOR, DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA 
Affiliation  INSTITUTE FOR AYURVED STUDIES AND RESEARCH  
Address  ROOM NO 112 PG DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA INSTITUTE FOR AYURVED STUDIES AND RESEARCH UMRI ROAD SECTOR 8 KURUKSHETRA
Sector-8 Kurukshetra
Kurukshetra
HARYANA
136118
India 
Phone  9996311778  
Fax    
Email  drsunititanwar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PINKI 
Designation  MS SCHOLAR PRASUTI TANTRA EVAM STREE ROGA 
Affiliation  INSTITUTE FOR AYURVED STUDIES AND RESEARCH  
Address  OPD NO 15 DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA INSTITUTE FOR AYURVED STUDIES AND RESEARCH UMRI ROAD SCETOR 8 KURUKSHETRA
UMRI ROAD SECTOR 8 KURUKSHETRA
Kurukshetra
HARYANA
136118
India 
Phone  7904001008  
Fax    
Email  pinkisheoran1998@gmail.com  
 
Source of Monetary or Material Support  
INSTITUTE FOR AYURVED STUDIES AND RESEARCH UMRI ROAD SECTOR 8 KURUKSHETRA HARYANA 136118 INDIA 
 
Primary Sponsor  
Name  INSTITUTE FOR AYURVED STUDIES AND RESEARCH  
Address  UMRI ROAD SECTOR 8 KURUKSHETRA 136118 HARYANA INDIA 
Type of Sponsor  Other [GOVERNMENT AYURVEDIC COLLEGE] 
 
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 PINKI  INSTITUTE FOR AYURVED STUDIES AND RESEARCH   OPD NO 15 DEPARTMENT OF PARSUTI TANTRA EVAM STREE ROGA INSTITUTE FOR AYURVED STUDIES AND RESEARCH SECTOR 8 UMRI ROAD
Kurukshetra
HARYANA 		 7904001008

pinkisheoran1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Krishna Ayush University INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N858||Other specified noninflammatory disorders of uterus. Ayurveda Condition: ARBUDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: CHARAK SIDHISTHAN CHAPTER 9, Procedure details: GROUP A KSHARA GUDIKA AND PANCHATIKTA GHRITA UTTARBASTI TIMING AFTER CESSATION OF MENSES FOR 3 CONSECUTIVE DAYS FOR 3 MONTHS WITH DOSE 4ML PURVAKARMA PATIENT ASKED TO EMPTY THE BLADDER ABHYANG AND SWEDAN OVER LOWER ABDOMEN VAGINAL WASH WITH TRIPHALADI KWATH PARDHAN KARMA PATIENT KEPT IN LITHOTOMY POSITION WITH WELL FLEXED THIGHS ANTISEPTIC DRESSING AND DRAPING DONE SPECULUM INSERTED IN VAGINA TO VISUALISE THE CERVIX CLEAN THE CERVIX BASTIPUTAK FILLED WITH SNEHA DRAVYA BASTINETRA LUBRICATED WITH SNEHA INSERTED IN VAGINA EMPTY THE BASTIPUTAK PLACE PICHU FOR 2 HOURS IN VAGINA ASKED TO REMOVE LATER ON PASCHAT KARMA ABHYANG AGAIN OVER LOWER ABDOMEN TILT THE TABLE HIGH ASKED PATIENT TO LIE DOWN FOR 30MINUTES AFTER COMPLETE REST SWEDAN AGAIN OVER ABDOMEN PATIENT ADVISED TO FOLLOW DIET AND PRECAUTIONS ABHYANG AND SWEDAN OVER LOWER ABDOMEN RECORD THE VITALS PARDHANKARMA )
(1) Medicine Name: PANCHATIKTA GHRITA, Reference: YOGRATNAKAR 25/362-365, Route: Vaginal, Dosage Form: Ghrita, Dose: 4(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: KSHARA GUDIKA, Reference: CHARAK CHIKITSA CHAPTER 12/43-46, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 3 Months
2Comparator ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: CHARAK SIDHISTHAN CHAPTER 9 , Procedure details: GROUP B PANCHATIKTA GHRITA UTTARBASTI ONLY TIMING - AFTER CESSATION OF MENSES FOR 3 CONSECUTIVE DAYS FOR 3 MONTHS PURVAKARMA PATIENT ASKED TO EMPTY THE BLADDER ABHYANG AND SWEDAN OVER LOWER ABDOMEN VAGINAL WASH WITH TRIPHALADI KWATH RECORD THE VITALS PARDHAN KARMA PATIENT KEPT IN LITHOTOMY POSITION WITH WELL FLEXED THIGHS ANTISEPTIC CLEANING AND DRAPING DONE SPECULUM INSERTED IN VAGINA TO VISUALISE THE CERVIX BASTIPUTAK FILLED WITH SNEHA DRAVYA BASTI NETRA LUBRICATED INSERTED IN VAGINA EMPTY THE BASTIPUTAK PUT A PICHU INSIDE VAGINA FOR 2 HOURS PASCHAT KARMA AGAIN LOCAL ABHYANG OVER SITE TILT THE TABLE HIGH ASKED PATIENT TO LIE ON TABLE FOR 30MINUTES ANG SWEDAN OVER SITE AGAIN AFTER REST)
(1) Medicine Name: PANCHATIKTA GHRITA, Reference: YOGRATNAKAR CHAPTER 25/362-365, Route: Vaginal, Dosage Form: Ghrita, Dose: 4(ml), Frequency: od, Duration: 3 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Patient having uterine fibroid size less than or equal to 5cm as per USG report, Single/Multiple fibroids. Patient either asymptomatic or having clinical signs and symptoms of uterine fibroid. Patient willing to participate in trial.  
 
ExclusionCriteria 
Details  Patient below age 20 years & above age 50 years.
Patient having fibroid size more than 5cm as per USG report.
Pregnancy, Unmarried, Post-Menopausal, Ovarian tumor, Tubo-ovarian mass, any Malignant tumor, sarcomatous changes in fibroid, fibroid with adenomyosis.
Patient with BMI less than 18.5/ Hyperacidity/ Ulcers (for oral drug).
Patient with HTN, TB, Uncontrolled DM and any other severe systemic diseases.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To resolve or reduce the size of Uterine Fibroid.
To improve the signs and symptoms associated with uterine fibroid. 		 To resolve or reduce the size of Uterine Fibroid reviewed on 30,60,90 days

To improve the signs and symptoms associated with uterine fibroid reviewed on 30,60,90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in other associated clinical features related to uterine fibroid.  Follow up for subjective criteria after every 1 month.
Follow up for objective criteria after every 1 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   Phase 2/ Phase 3 
Date of First Enrollment (India)   04/03/2025 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Women’s health should be a big focus in any female’s life. Fibroid is defined as non-cancerous growth in the uterus that can be developed during a woman’s childbearing years. Estimated incidence of uterine fibroid found approx. 20-40% women of reproductive age. Asymptomatic fibroid may present in 40-50% of women older than 40 yrs. of age. In today’s scenario, uterine fibroids are major health concern for women.  Fibroids dependent on estrogen & progesterone to grow, therefore relevant only during reproductive years, then they are expected to shrink after menopause. Regarding its treatment, surgical intervention has historically been mainstay of uterine fibroid treatment, Women looking for non-invasive methods. Due to modern science limitation, Ayurveda has great scope in the field to find out effective & non-invasive approach to manage the disease and improve the quality of life. On Exploring Samhita, study revealed that symptomatology of disease entity "Arbuda" correlated to Tumor. In classical texts, special reference of Arbuda of female reproductive system not available, but on basis of the origin in Garbhasya (uterus), it is compared with Garbhasya Arbuda. Aggravated Doshas, vitiating Mamsa, Rakta, Meda getting localized in garbhasya (uterus) produces local swelling in deep muscles which is round, fixed, small, big associated with pain, deep seated roots, increasing gradually. The principle of Samprapti Vighatan i.e. to break the pathogenesis used for the management of uterine fibroid. The protocol for the treatment of Garbhasya Arbuda is to dissolve/ to reduce the size. Here an attempt on Kshara Gudika described by Acharya Charaka via oral route and Panchatikta Ghrita mentioned in Yog Ratnakar via Uttar Basti.



 
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