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CTRI Number  CTRI/2024/08/072804 [Registered on: 21/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   To study the effect of lasuna churna and shatpushpa ghana vati in PCOS 
Scientific Title of Study   EFFECT OF LASHUNA CHURNA AND SHATAPUSHPA GHANA VATI IN PCOS - AN OPEN LABEL RANDOMIZED COMPARATIVE CLINICAL STUDY 
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 Anjum Maheboobpasha Mujawar  
Designation  Post graduate scholar 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysuru, Karnataka

Mysore
KARNATAKA
570028
India 
Phone  9591928173  
Fax    
Email  anjumujawar27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vidya Narayan 
Designation  Associate Professor 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysuru, Karnataka

Mysore
KARNATAKA
570028
India 
Phone  9980760076  
Fax    
Email  vidya.dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anjum Maheboobpasha Mujawar 
Designation  Post graduate scholar 
Affiliation  JSS Ayurveda Medical College and Hospital 
Address  OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysuru, Karnataka

Mysore
KARNATAKA
570028
India 
Phone  9591928173  
Fax    
Email  anjumujawar27@gmail.com  
 
Source of Monetary or Material Support  
OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysore, Karnataka, India, 570028 
 
Primary Sponsor  
Name  Dr Anjum Maheboobpasha Mujawar 
Address  OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysuru, Karnataka  
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 Anjum Maheboobpasha Mujawar  JSS Ayurveda Medical college and Hospital  OPD no. 9,Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road, alanhalli, Mysore, Karnataka , 570028
Mysore
KARNATAKA 
9591928173

anjumujawar27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS 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:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Lashuna churna, Reference: Kashyapa Samhita Kalpasthan Lashunakalpa Adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: Medicine will be discontinue during cycle
2Comparator ArmDrugClassical(1) Medicine Name: Shatapushpa ghana vati, Reference: Kashyapa Samhita Kalpashtana Shatapushpashatavari Kalpa adhyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: Medicine will be discontinue during cycle
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) Subjects with signs and symptoms of PCOS.
2) Subjects aged between 18- 40 years.
 
 
ExclusionCriteria 
Details  1) Subjects already on another drug treatment for PCOS like (OC Pills)
2) Subjects with other functional and structural pathology of reproductive organs.
3) Subjects with known cases of systemic disorders like renal disorders, and metabolic disorders like thyroid dysfunction and gastritis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Regularity of cycle and reduction in acne  5 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in hirsutism and Acanthosis nigricans  5 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/09/2024 
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="0"
Months="5"
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 is the common health hazard amongst women of reproductive age. It is characterized by oligo-ovulation or anovulation, features of androgen excess and ultrasound appearance of polycystic ovary. The prevalence of PCOS, a common female endocrine condition has been found to range from 2.2% to 26% globally and from 3.7% to 22.5% in India, depends on the diagnostic criteria utilized. PCOS affects 30-40% of women with amenorrhea where as it affects 85-90% women with oligomenorrhea. PCOS affects more than 80% of women who report with signs of androgen excess.

     PCOS is associated with weight gain, acne, hirsutism and impaired fertility due to chronic oligo-anovulation. In addition to androgen excess, insulin resistance is a central feature and women with PCOS have shown to be at increased risk of type 2 Diabetes, Hypertension and fatty liver disease. There are no curative options currentlyfor PCOS, therefore treatment aims to alleviate symptoms and prevent long-term complications, including cardiovascular events and endometrial cancer.

    The treatment available in contemporary science  like Hormonal therapy, OC pills, Insulin therapy,  prolonged usage end up with other metabolic disturbances, weight gain, acne, skin discolouration (acanthosis nigricans) and serious complications like Pulmonary thrombosis, Genital carcinoma, renal failure.

In Ayurvedic classics there areno direct references of this disease rather, symptoms are found under various diseased conditions at various references, like menstrual irregularitiesdescribed under the Ashtaartavadushti ,Pushpaghni, Jataharini mentioned in Kashyapa Samhita. RevatiKalpa Adyaya10bears similar features of hyperandrogenism like Vruthapushpa(anovulation), Sthoola(obesity), Lomaganda(hirsutism). Sushrutha Samhita gives the referencein ShukrashonitashuddhiAdhyayaabout Nasthartava ( amenorrhea) due to aggravated KaphaVattaDosha. In DoshadhatumalakshayavridhiAdhyaya there is reference about ArtavakshayaLakshanaslike YathochitakalaAdarshanamAlpadarshana(scanty flow). In Charak Samhita many scattered references are available in different chapters. In  GarbhavakrantiShareera, there is mention of Beejadushti which is characterised by Nashtartava(secondary amennorhea) and SantarpanaotthaVikarain the context of Sthoulya has been described. In AshtangaSangrahaPutarakameeeyaadhyaya there is description of AnartavaBhavaprakash under NanatmajaVyadhi Nashtartava has been explained. It may understood on the basis of Doshadushtiinvolvement of Dushya, Shrotas, Ama, Agani, AdhishthanaandVyadhiLaxanas.  Metabolic process is correlated with Dhatuagnivikara.
Therefore the drug selected for this study is Lashuna
 and Shatapushpa  has been mentioned in Kashyapa SamhitaBoth the drugs possess Katu Rasa, UsnaVirya, LaghuTikshnaGuna, KatuVipakaand Vatakapha  Hara, which acts as Artavapravartaka, Yonishodhana, Pradara, Vrushya, Garbhajanaka, Deepana, Pachana  Karma. 

 
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