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CTRI Number  CTRI/2025/03/081685 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of Endometriosis 
Scientific Title of Study   EFFICACY OF VIRECHANA KARMA, DASHAMOOLA TRIVRUTA TAILA MATRA BASTI AND GUDUCHYADI KASHAYA ORALLY IN THE MANAGEMENT OF ENDOMETRIOSIS - A SINGLE ARM OPEN LABELLED CLINICAL TRIAL  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Eknath Pradhan 
Designation  MS Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, INI, Jamnagar, Gujarat 
Address  Department of Prasutitantra Evum Streeroga, 5th floor academic building, Jamnagar,Institute of Teaching and Research in Ayurveda, Jamnagar Gujarat 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  7507223604  
Fax    
Email  pradhanpriyanka831@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Shilpa B Donga 
Designation  Prof. HOD  
Affiliation  Institute of Teaching and Research in Ayurveda, INI, Jamnagar, Gujarat 
Address  Department of Prasutitantra Evum Streeroga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9825646796  
Fax    
Email  drshilpadonga@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Shilpa B Donga 
Designation  Prof. HOD  
Affiliation  Institute of Teaching and Research in Ayurveda, INI, Jamnagar, Gujarat 
Address  Department of Prasutitantra Evum Streeroga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008 India

Jamnagar
GUJARAT
361008
India 
Phone  9825646796  
Fax    
Email  drshilpadonga@yahoo.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda , INI, Jamnagar, Gujarat 361008 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda 
Address  Institute of Teaching and Research in Ayurveda,Opp City B division Police station, Gurudwara road, Jamnagar, Gujarat 
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 Priyanka Eknath Pradhan  Institute of Teaching and Research in Ayurveda  OPD No A6,Streeroga OPD,Institute of Teaching and Research in Ayurveda,Opposite to B Division Police Station, Jamnagar 361008, Gujarat
Jamnagar
GUJARAT 
7507223604

pradhanpriyanka831@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N70-N77||Inflammatory diseases of female pelvic organs. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Virechana Karma (Procedure Reference: Kashyapa Samhita, Siddhi Sthana, 2/6, Procedure details: Deepana-Pachana for 3-5 days, Snehapana until Samyaka Snigdha Lakshana is obtained, Sarvanga Abhyanga and Swedana for 4 days, Virechana Karma 1 day, Samsarjana Krama as per Shudhi )
(1) Medicine Name: Trivruta Avaleha, Reference: Ashtanga Hridaya Kalpa Sthana-2/9, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-Basti Karma (Procedure Reference: Kashyapa Samhita, Siddhi Sthana, 1, Procedure details: Local Abhyanfa and Swedana at Kati, Adhodara and Prushta Pradesha Matra Basti)
(1) Medicine Name: Dashamoola Trivuta Taila , Reference: Vrddha Vagbhatta. Ashtangasamgraha with the Sashilekha Sanskrit Commentary by Indu by Prof. Jyotir Mitra. Uttaratantra, Guhyarogavigyana, Shloka no. Varanasi. Chowkhambha Sanskrit Series office,page no. 83 , Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
3Intervention ArmDrugClassical(1) Medicine Name: Guduchyadi Kashaya, Reference: Yogaratnakara, Visarpanidna-Chikitsa Prakaranam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -), Additional Information: (with Shuddha Guggulu 1gm as Prakshepa)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Both married and unmarried females of above age group
Patients having clinical signs and symptoms of endometriosis
Already known case of Endometriosis
Patients having CA-125 level less than 500U/ML
Patients having chocolate cyst size less than 7cm
Patients eligible for Virechana Karma and Basti
Patients willing to participate in trial 
 
ExclusionCriteria 
Details  Patients having age less than 18years and more than 50year
Patients having chocolate cyst size more than 7cm
Patients having CA-125 level more than 500U/ML
Patients having endometriosis of sites other than pelvis and scar endometriosis.
Known case of Carcinoma, Congenital anomaly or infectious diseases of reproductive tract like Tuberculosis, STDs, etc.
Patients with history of cardiac diseases, chronic liver disease, uncontrolled hypertension (Systolic BP above 160 & Diastolic above 100 mmHg), uncontrolled diabetes mellitus (above the range of 160 mg/dl - RBS)
Patients not eligible for Virechana Karma and Basti and not willing to participate in trial. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
(a)
Improvement in clinical features of Endometriosis
(b)Improvement in Quality of life. 
During the treatment period of 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
(a) Reduction in the size of Endometriosis.  After the treatment period of 4 months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 3 
Date of First Enrollment (India)   10/03/2025 
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  

 Introduction:

Endometriosis is defined as the presence of endometrial tissue (glands and stroma) outside the uterine cavity. It is benign but it is locally invasive, disseminates widely. Dysmenorrhea (Menstrual cramps), dyspareunia (painful intercourse), dyschezia (Obstructed defecation), dysuria (Discomfort urinating), pelvic pain and infertility are the prominent symptoms seen in women suffering from endometriosis.

Ayurveda explains that it is not always possible to name a disease in a definite term. endometriosis is not an exception for the same. Hence this disease has to be analyzed according to the Nidana Panchaka theory of Ayurveda based on the concepts of Dosha, Dushya, Srotas, Samprapti, and its management. The general treatment principles can be laid down by going through the treatment principles of Artavadushti, Pradara, Yonivyapad, Raktapitta, Gulma and Granthi. All these principles can be summarized as Shodhana therapy for Srotoshodhana and Shaman therapy as Vatanulomana and Lekhana.

 Why this topic:

There is no such effective treatment in modern science other than hormonal therapy and surgery.  Hormonal therapy has its own side effects and it is not a ‘complete cure’. Laparoscopy or surgical management is not opted by most of patients due to side effects and high cost of the treatment. Keeping all this views in mind, a better, safer

and effective therapy is needed for the present society which not only resolves the chocolate cyst, but also improves related menstrual problem and enhance the normal functioning of reproductive system. Looking into the etiopathogenesis and complications of endometriosis, it requires a systemic therapy for which Ayurveda may provide a hope through Shodhana and Shamana treatment. Thus, Present study has been planned to evaluate therapeutic efficacy of VIRECHANA KARMA, DASHAMOOLA TRIVRUTA TAILA MATRA BASTI AND GUDUCHYADI KASHAYA ORALLY in the management of endometriosis.

  Aims and Objectives:

   AIM

To evaluate the efficacy of Virechana followed by Dashamoola Trivruta Taila Matra Basti and Guduchyadi Kashaya orally in the management of Endometriosis.

 

    OBJECTIVES

1.    To assess the efficacy of the treatment protocol in VAS score of dysmenorrhea, dyspareunia and deep-seated pelvic pain.

2.    To evaluate the quality of life by using EHP-30 questionnaire.

 

 

 Materials and Methods:

 In the present study total minimum 15 diagnosed patients of endometriosis based on USG parameters, fulfilling the selection criteria will be registered. Single group of the patients will be treated with Virechna Karma followed by Dashamoola Trivruta Taila Matra Basti and Guduchyadi Kashaya Orally.

 Duration of study:

3 months along with 1 month of follow up.

Follow up:

After completion of therapy, follow up will be done for 1 month to assess the status of patient, where patient will be asked to report.

 Side Effects:

These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.

 Results and Discussion:

Data generated during the above study will be presented in a systemic manner as shall be analysed and the section where the important points of the Conceptual study, Clinical study, Pharmacological study will be discussed.

 

 

 

 
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