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CTRI Number  CTRI/2024/05/067175 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to know the effect of Ayurvedic drugs and diet in the management of Poly cystic ovarian syndrome  
Scientific Title of Study   A Randomized comparative clinical study to evaluate the efficacy of indigenous drugs and pathya ahara vihara in the management of PCOS. 
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 Lavanya Holeyannavar 
Designation  Assistant Professor  
Affiliation  Rajiv Gandhi University of Health Science Bangalore Karnataka 
Address  OPD NO 08 Prasuti tantra and stree Roga Department,Sanjeevini Ayurveda Medical College and Hospital,Hubli,Karnataka

Dharwad
KARNATAKA
580030
India 
Phone  9741879207  
Fax    
Email  lavanyaholeyannavar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gourish Asuti 
Designation  Professor and HOD 
Affiliation  Rajiv Gandhi University of Health Science Bangalore Karnataka 
Address  OPD NO 08 Prasuti tantra and stree Roga Department,Sanjeevini Ayurveda Medical College and Hospital,Hubli,Karnataka

Dharwad
KARNATAKA
580030
India 
Phone  9886669910  
Fax    
Email  drgourish83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gourish Asuti 
Designation  Professor and HOD 
Affiliation  Rajiv Gandhi University of Health Science Bangalore Karnataka 
Address  OPD NO 08 Prasuti tantra and stree Roga Department,Sanjeevini Ayurveda Medical College and Hospital,Hubli,Karnataka


KARNATAKA
580030
India 
Phone  9886669910  
Fax    
Email  drgourish83@gmail.com  
 
Source of Monetary or Material Support  
Sanjeevini Ayurveda Medical College and Hospital Hubli Dharwad Karnataka India 580030 
 
Primary Sponsor  
Name  Dr CC Hiremath 
Address  Sanjeevini Ayurveda Medical College and Hospital Hubli Dharwad Karnataka India 580030 
Type of Sponsor  Other [Principal Sanjeevini Ayurvedic Medical college and Hospital Hubli Dharwad Karnataka India 580030] 
 
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 Lavanya Holeyannavar  Sanjeevini Ayurveda Medical College and Hospital,Hubli,Karnataka  OPD NO 08 Prasuti Tantra and Stree Roga Department Sanjeevini Ayurveda Medical College and Hospital Hubli Karnataka India
Dharwad
KARNATAKA 
9741879207

lavanyaholeyannavar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sanjeevini Ayurveda Medical College and Hospital   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: ARTAVAVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: PC NORM, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: MC NORM, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Wheat flour as placebo
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Rotterdam creteria - With following symptoms of PCOS if any two of the following are present
(1) clinical or biochemical hyperandrogenism,
(2) Evidence of oligo-anovulation,
(3) Polycystic appearing-ovarian morphology on ultrasound
(4) Both married and unmarried females 
 
ExclusionCriteria 
Details  1 Patients suffering from Pelvic diseases like Endometriosis, Hydrosalphinx, Fibroid uterus, T.B, Carcinoma and Congenital deformities.
2 Patients having physiological infrequent menstruation.
3 Woman taking Oral Contraceptive Pills.
•Subjects with systemic illness interfering with the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is to prevent the symptoms and to restore menstrual cycle with proper ovulation in women health and to have healthy progeny and to relive the agony of patient with the help of a safe and cost effective medicaments.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 2/ Phase 3 
Date of First Enrollment (India)   07/06/2024 
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="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 ovary syndrome (PCOS) is a common hormonal condition that affects women of reproductive age. It usually starts during adolescence, but symptoms may fluctuate over time. PCOS can cause hormonal imbalances, irregular periods, excess androgen levels and cysts in the ovaries. Irregular periods, usually with a lack of ovulation, can make it difficult to become pregnant. PCOS is a leading cause of infertility. PCOS is a chronic condition and cannot be cured. However, some symptoms can be improved through lifestyle changes, medications and fertility treatments. PCOS a significant public health problem and is one of the commonest hormonal disturbances affecting women of reproductive age. The condition affects an estimated 8–13% of women of reproductive age, and up to 70% of cases are undiagnosed. The prevalence of PCOS is higher among some ethnicities and these groups of often experience more complications, in particular related to metabolic problems. The biological and psychological effects of PCOS, particularly those related to obesity, body image and infertility, can lead to mental health challenges and social stigma.

         In Ayurveda PCOS can be correlated to some extent with Artava-kshaya or with Pushpaghni jataharani The symptoms of Artava-kshaya is Yathochita-kala-adarshana means Apravrutti of Artava in its Yogya Kala (it may be delayed or absent), Artava is Alpa in pramana (scanty bleeding) and Yoni-vedana. The symptoms of Pushpaghni Jataharani is Vyartha-Pushpa-darshana (anovular menstruation), Sthula-Ganda-pradesha (cheeks are corpulent) and Lomayukta (hirsutism).

         In present era of globalization due to transient change in the life style to a more of  sedentary life style, exercise over time, lack of physical exercise, stress, high caloric food and indiscriminate dietary habits leading PCOS  A medical intervention of polycystic ovarian disease and syndrome includes hormonal therapies which have long term health consequences. There by researchers are looking for the ayurvedic (Herbal) medicine for the treatment of PCOS in alternative medicine which do not causes any side effects. The indigenous drugs namely MC-Norm and PC-Norm which are kapha-vatashamaka, having rochan, deepan, pachan, anulomaka properties. PCOS  is a life style disorder even  here is also an another attempt made to evaluate the effect Placebo – Wheat flour capsule with pathya aahara and vihara in the management of PCOS. Hence the study has undertaken to evaluate the effect of in indigenous compound  in the management of PCOS.

 
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