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CTRI Number  CTRI/2024/06/069012 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 15/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Role Of Ayurveda Treatment Protocol In Garbhasayagata Arbuda With Special Reference To Uterine Fibroid  
Scientific Title of Study   Clinical Study to Evaluate the Efficacy of Ayurveda Treatment Protocol in the Management of Garbhasayagata Arbuda WSR To 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 Roshika Pandey 
Designation  PG Scholor 
Affiliation  National Institute Of Ayurveda,Deemed To Be University(De Novo),Jaipur, Rajsthan 
Address  Room No. 304, 3rd Floor, Department Of Prasuti Tantra Evum Stri Roga, National Institute Of Ayurveda, Madav Vilas Palace Amer Road, Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9219394910  
Fax    
Email  roshikapandey@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Bharathi 
Designation  Professor And Head of Department 
Affiliation  National Institute Of Ayurveda, Deemed To Be University(DE NOVO),JAIPUR RAJASTHAN 
Address  Room No. 321, 3rd Floor, Department Of Prasuti Tantra Evum Stri Roga, National Institute Of Ayurveda, Madav Vilas Palace Amer Road, Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9492047131  
Fax    
Email  baruhunt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Roshika Pandey 
Designation  PG Scholor 
Affiliation  National Institute Of Ayurveda,Deemed To Be University(De Novo),Jaipur, Rajsthan 
Address  Room No. 321, 3rd Floor, Department Of Prasuti Tantra Evum Stri Roga, National Institute Of Ayurveda, Madav Vilas Palace Amer Road, Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9219394910  
Fax    
Email  roshikapandey@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda,Jaipur Rajasthan 
 
Primary Sponsor  
Name  National Institute of AyurvedaJaipur Rajasthan 
Address  National Institute Of Ayurveda, Madav Vilas Palace Amer Road, Jaipur Rajasthan 302002 
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 Roshika Pandey  National Institute Of Ayurveda,Deemed To Be University(De Novo),Jaipur, Rajsthan  Opd no. 26,27, Ground floor,Opd Building, National Institute Of Ayurveda,Deemed To Be University(De Novo),Jaipur, Rajsthan
Jaipur
RAJASTHAN 		 9219394910

roshikapandey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D259||Leiomyoma of uterus, unspecified. Ayurveda Condition: ARBUDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: , Procedure details: 20ml of blood letting will be done in 1 sitting and repeated 3 times i.e. every week for 1 month. Total blood letting will be 80 ml.))
2Intervention ArmProcedure-bastikarma, बस्तिकर्म (Procedure Reference: Su.S.Chi 38/82,, Procedure details: Lekhana basti karma, Dose 500ml, Per rectal after cessation of menses for 7days in 2 consecutive mestrual cycle)
(1) Medicine Name: Usakadi gana kwatha, Reference: Su.S.Chi 38/82,, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days
3Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Bhaisajya Ratnawali,Karna roga adhikar, Procedure details: dose-5ml route-Intra- uterine duration-3 days after 7 th day of menses or after stoppage of bleeding in last 3 days of lekhana basti for 3 consecutive menstrual cycle, after food.)
(1) Medicine Name: Apamargkshar taila, Reference: Bhaisajya Ratnawali,Karna roga adhikar, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Days
4Intervention ArmProcedure-yoni picu, योनि पिचु (Procedure Reference: Bhaisajya Ratnawali,Karna roga adhikar, Procedure details: From the 7 th day of menses for 7 day,after food.)
(1) Medicine Name: Apamargkshar Taila, Reference: Bhaisajya Ratnawali,Karna roga adhikar, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 7 Days
5Intervention ArmDrugClassical(1) Medicine Name: Kanchanar Guggulu, Reference: Bhaisajya Ratnawali, Galganda Adhya, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1.Having fibroid size upto 5 cm(confirmed by U.S.G)
2. Single or multiple fibroid
3. Female patient of age of 21-50
4. Only married females. 
 
ExclusionCriteria 
Details  Having any kind of malignancy.
2. Patient having bleeding due to abortion or any pathological condition.
3. Patients having coagulation disorders.
4. Patients having IUCDs in-situ.
5. Patient having fibroid larger than 5cm.
6. Pregnancy with fibroid.
7. Anaemic patient whose haemoglobin is below 10% 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the size of uterine fibroid  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Dysmenorrhea.
Menorrhagia  		 90 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/07/2024 
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="0"
Months="3"
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   PRIMARY PURPOSE:- TREATMENT
NEED OF STUDY:-Changing lifestyle in this era is leading to various disturbance in the normal physiological
phenomena and benign and malignant growths are getting lead off place nowadays. The incidence
of uterine fibroids accounted for 9.64 million globally in 2019, a significant increase compared
with the number in 1990 i.e 67.07%  . The prevalence of it also rising up day by day leading
difficult situation for the female and the management of uterine fibroid are mostly invasive type
such as myomectomy, uterine artery embolization (UAE),Contraceptive pills,intrauterine devices
(IUD) and finally hysterectomy in modern science.
Where as Ayurveda system of medicine also have its own line of treatment which are very effective
and it also consists of surgical and parasurgical measures. And keeping this thing in mind and also to
propagate the knowledge of our great Acharyas some of common para-surgical measures such as
Siravedha and Panchakarma measures and Lekhana Basti,Uttar Basti and oral medication such as
Kanchanar gugulu which are less invasive had been selected for the study so that it could be
managed with few complications.
AIMS & OBJECTIVES-
AIM
To evaluate the efficacy of Ayurveda treatment protocol in management of Garbhasayagata
Arbuda.
Primary Objective
1. To study the Ayurveda literature on Garbhasayagata Arbuda
2. To evaluate the efficacy of Ayurveda treatment protocol to change in the size of
Garbhashyagata Arbuda.
Secondary Objective
To see the effect of trial drug and procedure on clinical features of the Garbhashyagata Arbuda.

RESEARCH QUESTION(S)
Research Question Is there any efficacy of Ayurveda treatment protocol in management of
Garbhasayagata Arbuda?

Hypothesis
H0: There is no efficacy of Ayurveda treatment protocol in management of
Garbhasayagata Arbuda.

HA: There is efficacy of Ayurveda treatment protocol in management of
Garbhasayagata Arbuda.
Trial Drugs and Procedure:
1. Siravedha
2. Lekhana Basti
3. Uttar Basti with Apamargakshar taila
4. Yoni Pichu with Apamargakshar taila
5. Oral medication i.e. Kanchanar gugulu
LABORATORY INVESTIGATIONS:
Before Treatment
1. CBC
2. Random Blood Sugar (RBS)
3. Liver function test (LFT)
4. Renal function test (RFT)
5. Clotting time (CT)
6. Bleeding time (BT)

7. Human Immuno-Deficiency Virus (HIV)
8. Venereal disease research laboratory (VDRL)
9. Hepatitis B surface Antigen (HbsAg),
10. Urine routine & microscopic
11. USG for Uterus and adnexa
During treatment: Hb % if needed
After Treatment:
1. CBC
2. RBS
3. Liver function test (LFT)
4. Renal function test (RFT)
5. USG for uterus and adnexa
 
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