| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Intervention Arm | Procedure | - | 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 | | 3 | Intervention Arm | Drug | Classical | | (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. |