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CTRI Number  CTRI/2026/03/106710 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 22/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   Using Dashamoola Oil Enema Therapy to Help Manage PCOS A Clinical Study 
Scientific Title of Study   A Clinical Study To Evaluate The Effect Of Dashamoola Taila Matra Basti In The Management Of PCOS Pushpaghni Jataharini 
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 LEELA RAMAKRISHNAN 
Designation  Associate Professor, M.S. (Ayu) Dept.of PG Studies in Prasuti Tantra Evam Striroga 
Affiliation   
Address  Room No 13 PG Department of Prasuti Tantra Evam Striroga Frist Floor Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpettai Chennai-600123, Tamilnadu
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpettai Chennai-600123 Tamilnadu
Thiruvallur
TAMIL NADU
600123
India 
Phone  9942360360  
Fax    
Email  drleelaa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR LEELA RAMAKRISHNAN 
Designation  Associate Professor, M.S. (Ayu) Dept.of PG Studies in Prasuti Tantra Evam Striroga 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Room No 13 PG Department of Prasuti Tantra Evam Striroga Frist Floor Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpettai Chennai-600123, Tamilnadu
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpettai Chennai-600123 Tamilnadu
Thiruvallur
TAMIL NADU
600123
India 
Phone  9942360360  
Fax    
Email  drleelaa@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MUNGRE SWATI DAMODHAR 
Designation  2nd year PG Scholar, Dept of PG Studies in Prasuti Tantra Evam Striroga 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  Room No 13 PG Department of Prasuti Tantra Evam Striroga Frist Floor Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpettai -600123 Tamilnadu
Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpettai Chennai-600123 Tamilnadu
Thiruvallur
TAMIL NADU
600123
India 
Phone  7507954976  
Fax    
Email  8swatimungre@gmail.com  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu. 
 
Primary Sponsor  
Name  Dr Mungre Swati Damodhar 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu. 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
DR LEELA RAMAKRISHNAN  Dept. of PG Studies in Prasuti Tantra Evam Striroga Sri Jayendra Saraswathi Ayurveda College and Hospital,4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123, Tamilnadu. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR LEELA RAMAKRISHNAN  DR LEELA RAMAKRISHNAN  Department of Prasuti Tantra Evam Striroga, Frist Floor, Sri Jayendra Saraswathi Ayurveda College and Hospital, 4/295, Bangalore Chennai Highway Road, Nazarathpettai, Chennai-600123,Thiruvallur Tamilnadu
Thiruvallur
TAMIL NADU 		 9942360360

drleela@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital Department of Ayurveda, SCSVMV, Nazarathpet Chennai, 600123  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: PCOD,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Bhashjya Ratnavali Shiro Roga Adhikara, Procedure details: Dashamoola Taila Matra Basti will be administrated for 7 days 72 ml/day after food for 2 consecutive cycles. )
(1) Medicine Name: Dashamoola Taila, Reference: Bhashjya Ratnavali Shiro Roga Adhikar, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) Age group between 16 to 40 years

2) Ultrasound findings of polycystic ovaries as per international criteria (ovarian volume & no of follicles)

3) Secondary amenorrhea due to PCOS

4) Oligomenorrhea due to PCOS
 
 
ExclusionCriteria 
Details  1) Age group below 16 years and above 40 years

2) primary amenorrhea

3) Thyroid disorder

4) Hyperprolactemia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Dashamoola Taila Matra Basti in the management of Polycystic Ovaries Syndrome(PCOS) by regulating the menstrual cycle.  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effectivness of Dashamoola Taila Matra Basti in the management of Polycystic Ovaries Syndrome(PCOS) by regulating the menstrual cycle.  7 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 4 
Date of First Enrollment (India)   05/04/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Polycystic Ovarian Syndrome (PCOS) is the most common endocrinopathy among women of reproductive age associated with lifestyle factors such as sedentary habits, increased intake of junk food and stress. According to WHO, Incidence of PCOS is 6 to 13 percent in women of reproductive age and upto 70 percent of cases are undiagnosed. The occurrence of PCOS in India varies significantly ranging from 3.7 percent to 22 percent. Exact pathophysiology of PCOS is not clearly understood. The medical intervention of PCOS is oral Contraceptives, Insulin Sensitizers, Aromatase inhibitors, Androgen receptor antagonists, Gonadotropin therapy, Surgical intervention Laparoscopic ovarian diathermy. These hormonal therapies have longterm health consequences, Hence researchers are looking to the Ayurveda medicines for the treatment of PCOS. In this study, Dashamoola Taila Matra Basti is administrated. The drugs of Dashamoola is Katu-tikta Rasa, Laghu-Ruksa Guna, Katu Vipaka and Ushna Virya, Dashamoola Taila drugs having the properties of Kapha Vatahara, Lekhaniya and also Dipana- Pachana. The present study is aimed to bring out the influence of Ayurveda in the management of PCOS. Dashamoola Taila Matra Basti resolves the ovarian volume, regularies the menstrual cycle and restore the ovulation. Since the prevalence of PCOS is high, the present study on A CLINICAL STUDY TO EVALUATE THE EFFECTIVNESS OF DASHAMOOLA TAILA MATRA BASTI IN THE MANAGEMENT OF POLYCYSTIC OVARIAN SYNDROME (PUSHPAGHNI JATAHARINI) is selected with a hope to provide better results through Ayurvedic system. 
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