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CTRI Number  CTRI/2024/05/066674 [Registered on: 02/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurveda treatment protocol in the management of Artavadushti W.S.R. to non-obese PCOS 
Scientific Title of Study   Efficacy of Nitya Virechana with Naracha Choorna, Sahacharadi Taila Matra Basthi and Shatapushpadi Yoga orally in the management of Artavadushti W.S.R. to non-obese polycystic ovarian syndrome: 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  Arya Shaji 
Designation  M.S. Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9961391504  
Fax    
Email  shajiarya084@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpa B Donga 
Designation  Professor [I/C HOD] 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9825646796  
Fax    
Email  drshilpadonga@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shilpa B Donga 
Designation  Professor [I/C HOD] 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar


GUJARAT
361008
India 
Phone  9825646796  
Fax    
Email  drshilpadonga@yahoo.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Opp.B-Division Police Station, Gurudwara Road, Jamnagar, Gujarat 361008 
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 Arya Shaji  PG Hospital, OPD no. 07, Institute of Teaching and Research in Ayurveda, Jamnagar   Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar
GUJARAT 
09961391504

shajiarya084@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 (INI), Jamnagar   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: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Ashtanga Hridaya Chikitsasthana Adhyaya 21, Procedure details: Local Abhyanga and Swedana at Kati, Prushtha and Adhodara Pradesha, Matra Basti)
(1) Medicine Name: Sahacharadi Taila, Reference: Ashtanga Hridaya Chikitsasthana Adhyaya 21, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
2Intervention ArmDrugClassical(1) Medicine Name: Naracha Choorna, Reference: Sharangdhara Samhita Madhyamakhanda Adhyaya 6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Warm water), Additional Information: -
3Intervention ArmDrugOther than Classical(1) Medicine Name: Shatapushpadi Yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Goghrita), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Both married /unmarried patients in the age group of 18-40 yrs.
Diagnosed cases as per ASRM (American society for reproductive medicine)/ESHRE (European society of human reproduction and embryology) criteria for PCOS.
Patient willing to give written informed consent by themselves
BMI less than or equal to 25 kg/m2
 
 
ExclusionCriteria 
Details  Age group less than 18yrs and more than 40yrs
BMI more than 25 Kg/m2
Patients suffering from chronic Pelvic diseases like (Endometriosis, PID, Uterine Fibroid, Menorrhagia, etc.)
Organic lesions of reproductive tract like Tuberculosis, Carcinoma and congenital deformities and Sexually Transmitted Diseases.
Patients with history of cardiac diseases, uncontrolled hypertension (Systolic BP above 160 & Diastolic above 100mmhg), uncontrolled Diabetes Mellitus (FBS- above the range of 160 mg/dl)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It is Expected that trial drugs will help in the reduction of ovarian volume.  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
It is expected that trial drugs will help in the regulation of menstrual pattern and induce ovulation.  2 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/05/2024 
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="1"
Months="6"
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  

Introduction:

 Polycystic Ovarian Syndrome [PCOS] is the most common endocrine and metabolic disorder in a woman of reproductive age. It is a multifactorial and polygenic condition. It is heterogenous by nature and can be defined by a combination of sign and symptoms of androgen excess and ovarian dysfunction in the absence of other specific diagnosis. It is a complex syndrome showing the clinical features of an endocrine/metabolic disorder, including hyperinsulinemia and hyperandrogenism. Clinically it is characterized by menstrual abnormalities, hirsutism, acne, obesity, insulin resistance and baldness.

      There are two phenotypes of PCOS, obese and non-obese with different biochemical hormonal and metabolic profiles. Although a majority of cases with PCOS are obese/overweight, a small but significant proportion of patients present with normal body mass index or low BMI (≤25 kg/m2) that makes diagnosis work up and therapeutic approach more difficult. These cases of PCOS are termed as non-obese PCOS. Causative factor for non-obese PCOS are stress factor, nutritional factor and genetic factor. Women with non-obese PCOS may struggle with irregular periods, anxiety, uncontrolled blood sugar, fertility problems, and other caused by elevated androgen (testosterone) levels such as excess facial hairs and acne.

 

Rationale for selection of the topic:

PCOS is a global health issue for women’s health in current scenario due to changes in life style, habits and mental stress from menarche to menopause. Overweight women with PCOS may be diagnosed with their absent or irregular 3 cycles when they are still in high school. Comparatively, non-obese PCOS women may not diagnosed until they struggle to conceive.

There are only few research works available on non-obese PCOS.There is no fixed protocol or interventional drug or procedure to approach non-obese PCOS patients.

                                 Drugs for the selected study are Naracha Choorna, Sahacharadi Taila and Shatapushpadi Yoga. Acharya Charaka has said that repeated elimination of Doshas should be done by Mrudu Virechana drug in weak patients who have more Doshas. Naracha Choorna helps in Vatanulomana. Sahacharadi Taila is Vatashamaka and Yonidoshahara due to Ushna-Tikshna properties. Acharyas have mentioned Rasayana and Doshanusara Chikitsa in Artvadushti .So, Shatapushpadi Yoga that contains Shatapushpa,Shatavari and Brahmi has been selected for the same.

 

Aim: - To evaluate  the efficacy of Nitya Virechana with Naracha Choorna, Sahacharadi  Taila Matrabasti and    Shatapushpadi   Yoga  orally in the management of non-obese PCOS.

Objectives:  

•       To assess the efficacy of Nitya Virechana with Naracha choorna, Sahacharadi Taila Matra Basthi  and   Shatapushpadi  Yoga  orally  on ovarian morphology.

•        To assess the efficacy of Nitya Virechana with Naracha Choorna orally, Sahacharadi Taila Matra Basthi and    Shatapushpadi  Yoga  orally on menstrual abnormality.

 

Materials and Methods: Primarily, subjects will be selected on the basis of symptoms of PCOS. Further, if subjects fulfill the inclusion criteria and suspected pathologies if any, are ruled out, then appropriate written informed consent will be taken from the subjects to participate in the study. The cases will be registered for the clinical trial from O.P.D and I.P.D of Department of Prasuti Tantra Evam Stree Roga or such cases referred from other departments of ITRA Jamnagar irrespective of Caste and religion . Patients will be screened and examined with the help of Rotterdam criteria of non-obese (BMI ≤25 kg/m2) PCOS based on clinical and USG parameters. Further assessment will be done according to specially designed proforma.Sample size of the study will be 20, assigned in a single group.Naracha choorna for Nitya virechana orally ,Sahacharadi taila Matra Basti in two consecutive menstrual cycle and Shatapushpadi Yoga orally will be administerd for 2 months.Followup period will be 1 month.

Results and Discussion: Data generated during the above study will be presented in a systemic manner and shall be analysed statistically. The important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.

Side Effects: This drug has no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.

 
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