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CTRI Number  CTRI/2025/04/084736 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 22/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Management ]  
Study Design  Single Arm Study 
Public Title of Study   Oral medication for PCOS patient for treating irregular periods  
Scientific Title of Study   A clinical study to evaluate the effect of Latakaranjaadi Yoga 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 Himanshi Kharya  
Designation  Pg Scholar  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi  
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi Laxminarayana Nagara

Udupi
KARNATAKA
574118
India 
Phone  8109227956  
Fax    
Email  himanshikharya0000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suchetha Kumari  
Designation  Assistant Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi  
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi Laxminarayana Nagara

Udupi
KARNATAKA
574118
India 
Phone  9448529574  
Fax    
Email  suchetha.sdm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Himanshi Kharya  
Designation  Pg Scholar  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi  
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi Laxminarayana Nagara

Udupi
KARNATAKA
574118
India 
Phone  8109227956  
Fax    
Email  himanshikharya0000@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Dr Himanshi Kharya  
Address  Harsha gift centre jhanda bazar Sihora District Jabalpur PIN code 483225  
Type of Sponsor  Other [Self ] 
 
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 Himanshi Kharya   Sri Dharmasthala Manjunatheshwara hospital   Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi Department of Prasuti Tantra Evum Stree Roga Laxminarayana Nagara Kuthpady- 574118
Udupi
KARNATAKA 
8109227956

himanshikharya0000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE OF SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA UDUPI  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: JATAGHNI/PUTRAGHNI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Latakaranjaadi Yoga , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ushnodaka ), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Subject fulfilling diagnostic criteria of PCOS
Amenorrhea
Anovulation
Hirsutism
Acanthosis nigricans
Polycystic ovaries morphology on ultrasound  
 
ExclusionCriteria 
Details  Any other systemic diseases which interfere with the treatment
Pregnant women and lactating mothers  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Latakaranjaadi Yoga in the management of PCOS   3 months  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of Latakaranjaadi
Yoga in the management of PCOS symptoms  
Usg will be done on the day 90 to note the size of follicle, ovarian volume , endometrial thickness  
 
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 2 
Date of First Enrollment (India)   23/04/2025 
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="0"
Months="10"
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 prevalent endocrinopathy. It is a common metabolic-endocrine-reproductive disorder. PCOS is a heterogeneous disorder characterized by amenorrhea,oligo-ovulation or anovulation, signs of elevated androgen levels and multiple small ovarian cysts on one or both ovaries. The pathophysiology of PCOS involves primary defects in the hypothalamic-pituitary axis, insulin secretion and action, and ovarian function. Excess insulin stimulates the ovaries to produce large amounts of male hormone, testosterone which may prevent the ovaries from ovulating, thus causing infertility. Long course of disease without any management may reach the extreme in the form of Cardiovascular disorders, Endometrial cancer, hypertension, dyslipidemia, obesity, diabetes mellitus.

According to classics, PCOS cannot be correlated to a single entity. As PCOS itself says it is a group of symptoms. In Ayurveda there are many evidences which can mimic the features of Polycystic ovarian syndrome. Yonivyapads like Vandya. Artavavyapads like Nashtartava , Artava kshaya . It can also be correlated with Pushpaghni jaathaharini from Kashyapa Samhita. It leads to dosha dushya dusthi along with Medodushti and it adversely vitiates the Artava of women thus, making her infertile.

PCOS is a syndrome for which there is no permanent remission. Ovulation therapies and symptomatic treatments are practiced but complete cure is not attained. So there is increased demand to approach the problem from view of Ayurvedic system. 

So in this thesis study is planned with the churna of Kuberaksha Beeja Majja, Shunthi, Methika, Rasona, Hingu, Sauvarchala Lavana, and Manjishta. These drugs are having katu, tikta rasa and usna virya, and vatakaphashamaka properties. Some of the drugs are also Mehaghana, and Vrishya in nature.

Hence these studied drugs may prove beneficial in the management of PCOS.

 
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