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CTRI Number  CTRI/2024/02/063315 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 23/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurveda Management of Poly cystic ovarian syndrome 
Scientific Title of Study   Management of Polycystic ovarian syndrome (PCOS) with multimodal Ayurveda treatment- A single arm prospective clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NO any  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nilofar Shaikh 
Designation  Associate Professor 
Affiliation  JS Ayurveda Mahavidhyalaya 
Address  132 OPD prasutitantra Evam Streeroga Department JS Ayurved Mahavidyalaya

Kheda
GUJARAT
387001
India 
Phone  9638508994  
Fax    
Email  Shaikhnilofar12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Matangee Pandya 
Designation  Assistant Professor 
Affiliation  JS Ayurveda Mahavidhyalaya 
Address  132 OPD prasutitantra Evam Streeroga Department JS Ayurved Mahavidyalaya
132 OPD prasutitantra Evam Streeroga Department JS Ayurved Mahavidyalaya
Kheda
GUJARAT
387001
India 
Phone  9106241594  
Fax    
Email  drmatangee144@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nilofar Shaikh 
Designation  Associate Professor 
Affiliation  JS Ayurveda Mahavidhyalaya 
Address  132 OPD prasutitantra Evam Streeroga Department JS Ayurved Mahavidyalaya


GUJARAT
387001
India 
Phone  9638508994  
Fax    
Email  Shaikhnilofar12@gmail.com  
 
Source of Monetary or Material Support  
JS Ayurved Mahavidyalaya Nadiad 
 
Primary Sponsor  
Name  Nilofar Shaikh 
Address  Prasutitantra evam streeroga department JS Ayurved Mahavidyalaya Nadiad 
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 
DrNilofar Shaikh  JS Ayurveda Mahavidyalaya and PD Patel Ayurveda Hospital  132 OPD prasutitantra evam streeroga department
Kheda
GUJARAT 		 9638508994

Shaikhnilofar12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maganbhai Adenwala Mahagujarat University Institutional Ethics committee for human research  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-nasyam/ nastam, नस्यम्/ नस्तम् Pradhan Karma(Procedure Reference: Cha. Si. 2/22, Procedure details: 3 sittings of 7 days with 21 days gap between each Sitting. )
2Intervention ArmDrugOther than Classical(1) Medicine Name: SJ powder, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: krishna tila guda kwatha), Additional Information: -
3Intervention ArmDrugClassical(1) Medicine Name: Kanchanara Guggulu, Reference: Shadangadhara Samhita Madhyama khanda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 900(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -
4Intervention ArmDrugClassical(1) Medicine Name: Pathadi Kwatha, Reference: Su.Sha.2/16, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: Pathadi Kwatha, Reference: Su.Sha.2/16, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  2. Patients with any 3 or more clinical features of PCOS like;
Oligomenorrhoea: Menstrual cycle interval: 35-90 days, Acne/ oily skin ,Acanthosis nigricans, Excessive hair on the face or body (Hirsutism ), Male-pattern baldness or hair thinning.
3. Weight gain (BMI- 25.0—29.9)
 
 
ExclusionCriteria 
Details  Age: below 18 years and above 40 years
Sex:Male 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
regular menstrual cycle  baseline,12wks,16wks 
 
Secondary Outcome  
Outcome  TimePoints 
No multiple follicles in
ovaries/ ovarian volume will decrease 		 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/03/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 one of the most common endocrine and metabolic   disorders affects an estimated 8–13% of reproductive-aged women.1 Prevalence of PCOS in India ranges from 3.7 to 22.5 per cent depending on the population studied and the criteria used for diagnosis. 2 Polycystic ovary syndrome (PCOS) is a complex condition characterized by elevated androgen levels, menstrual irregularities, and/or small cysts on one or both ovaries. Clinical manifestations of this syndrome such as irregular menstrual cycle, acne or oily skin, excessive hair on the face or body, male-pattern baldness or hair thinning, weight gain, infertility, biochemical and hormonal disturbances has been widely described. Yet, these symptoms are often related to deterioration in the woman’s self-esteem and self-image and may affect their health-related quality of life (HRQoL), particularly in relationship with psychosocial domains3. Ayurveda understands a disease based on the Doshas and Dushyas involved in disease manifestation. Hence, the specific nomenclature of the diseases is not much essential. There is no direct reference to PCOS in Ayurveda, but the symptoms can be seen in conditions mentioned in Ayurveda literature like Artava Kshaya4, Ksheena Artava5 and Pushpaghni jathaharini6. As per the WHO; “There is no cure for PCOS, but treatments can improve symptoms. Contraceptive pill can help to regulate the menstrual cycle and reduce symptoms. Other medicines can reduce acne or unwanted hair growth caused by PCOS.  In-vitro fertilization (IVF) may be used but it has some risks.”7   Non-promising management with its additional adverse effect is a big challenge in the conventional medical care for PCOS. Patients are seeking alternative and complimentary therapy to overcome this challenge. In present clinical study the oral administration of SJ Powder (Combination of Shatapushpa,Jatamansi),   Pathadi Kwatha, Kanchanara Guggulu, and Nasya (Nasal instillation) of Shatapushpa Taila have been attempted to evaluate their effect in selected cases of PCOS. 
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