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CTRI Number  CTRI/2025/01/079627 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 26/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To study the effect of Jyothishmathi patra roasted in ghee powdered and administered with durva swarasa in reduced menstruation with poly cystic ovarian syndrome 
Scientific Title of Study   TO Evaluate the clinical efficacy of ghrita bhrista Jyothishmathi patra with durva swarasa in Artava kshaya in poly cystic ovarian syndrome-A Pilot 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  Nazeesh parveen banu 
Designation  student 
Affiliation  sushrutha ayurvedic medical college 
Address  opd no 9, ground floor, Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, Jigani ,Bengaluru
Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru
Bangalore Rural
KARNATAKA
560105
India 
Phone  8688951170  
Fax    
Email  nazeesh.r2001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nazeesh parveen banu 
Designation  student 
Affiliation  sushrutha ayurvedic medical college 
Address  OPD NO 9 , ground floor Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru
Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru
Bangalore Rural
KARNATAKA
560105
India 
Phone  8688951170  
Fax    
Email  nazeesh.r2001@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Ranjitha BM 
Designation  Associate Professor 
Affiliation  sushrutha ayurvedic medical college 
Address  OPD NO 9, Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru
Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru
Bangalore Rural
KARNATAKA
560105
India 
Phone  9480194926  
Fax    
Email  drranjithabm@gmail.com  
 
Source of Monetary or Material Support  
Sushrutha Ayurveda Medical College garden Sushrutha ayurveda medical college and hospital,Prashanti kuteeram,Svyasa Campus Jodi Bingapura, Jigani Hobli,Anekal Taluk bengaluru 560105 Karnataka, India 
 
Primary Sponsor  
Name  Sushrutha Ayurveda Medial college and Hospital 
Address  Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru 
Type of Sponsor  Private hospital/clinic 
 
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 
DrRanjitha B M  Sushrutha Ayurveda Medical College and hospital  OPD NO 9, Ground floor, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru
Bangalore Rural
KARNATAKA 
9480194926

drranjithabm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAMC&H-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N74||Female pelvic inflammatory disorders in diseases classified elsewhere. Ayurveda Condition: ARTAVAKSHAYAH, (2) ICD-10 Condition:N74||Female pelvic inflammatory disorders in diseases classified elsewhere. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Jyothishmathi patra and Durva swarasa, Reference: Bhaishajya Ratnavali chapter 67 , shloka number 28, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Durva swarasa), Additional Information: -ghrita bhrista Jyothishmathi patra
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Women of age group between 18-35 years
2. Oligomenorrhea/hypomenorrhea
3. Diagnosed case of polycystic ovaries through USG 
 
ExclusionCriteria 
Details  1. Pelvic inflammatoy disease
2. Abnormal uterine bleeding
3. Fibroid uterus
4. endometriosis
5. Adenomyosis
6. Hormonal disorder except PCOS
7. Congenital anomalies of female genital tract  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The study on the clinical effi cacy of ghrita bhrista jyothishmati patra with durva swarasa in managing artava kshaya with in the context of polycystic ovarian syndrome aims to explore an ayurvedic approach to improving menstrual health where there will be Normalcy of duration and regularization of menstrual flow is expected.  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Normalcy of duration and regularization of menstrual cycle   After 2 months 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   15/02/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Artava Kshaya is described as a condition where there is diminution or reduction in menstrual flow,irregularity or cessation of menstruation and disruption in the normal menstrual cycle1.PCOS(polycystic ovarian syndrome) is the most common endocrine disorder in a women of reproductive age.Diagnosis is based upon the presence of any two of the following criteria 1)Oligoand/anovulation  2)Hyperandrogenism (clinical and/or biochemical). 3)polycystic ovaries.Ovarian volume increased≥10cm3. Presence of multiple(≥12)follicles cysts measuring about 2-9mm in diameter around the cortex2. Incidence of PCOS is estimated to be around 5-10% among women of reproductive age and Prevalence rates for PCOS range from 6%-20% with variations influenced by factors such as ethnicity and regional demographics. specific populations, particularly those with family history of PCOS or associated metabolic conditions may exhibit higher Prevalence rates3. Artava Kshaya can be understood as a vata-kaphaja vikara,where vata governs physiological functions with apana vata ensuring the proper flow of artava. Kapha with its Avrodhaka guna can block the Artava vaha srotas, contributing the pathogenesis of Artava Kshaya along with Vata.In Bhaisajya Ratnavali acharya has mentioned that Jyothishmati patra (Celastrus paniculatus) roasted with Goghrita ground with durva swarasa (Cynodon dactylon) act as artavapravartaka4. Jyotishmati ( Celastrus paniculatus) with its katu-tiktarasa, teekshnaguna, ushnaveerya and katuvipaka helps in vilayana of kapha and alleviating vata dosha there by clearing obstructions, it also promotes agnivardhana, amapachana, leading to proper formation of rasadidhatu. since Artava is the upadhatu of rasadhatu, this process supports proper artava formation5. 
 
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