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CTRI Number  CTRI/2025/08/092299 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 02/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   EFFECTIVENESS OF ARKAPUSHPA TAILA OVER SHATAPUSHPA TAILA NASYA IN ARTAVAKSHAYA WITH SPECIAL REFERENCE TO PCOD 
Scientific Title of Study   A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARKAPUSHPA TAILA OVER SHATAPUSHPA TAILA PRATIMARSHA NASYA IN ARTAVAKSHAYA WITH SPECIAL REFERENCE TO PCOD 
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 Akshata Paramagoudar  
Designation  Post graduate scholar 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college and Hospital KOPPAL  
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college Gavimath Campus Koppal KARNATAKA 583231 India

Koppal
KARNATAKA
583231
India 
Phone  7019017437  
Fax    
Email  paramagoudarakshata@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Niveditha Somalapur 
Designation  Associate Professor 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college and Hospital KOPPAL  
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college Gavimath Campus Koppal KARNATAKA 583231 India

Koppal
KARNATAKA
583231
India 
Phone  9886800413  
Fax    
Email  nivedita.somalapur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Niveditha Somalapur 
Designation  Associate Professor 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college and Hospital KOPPAL  
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college Gavimath Campus Koppal KARNATAKA 583231 India

Koppal
KARNATAKA
583231
India 
Phone  9886800413  
Fax    
Email  nivedita.somalapur@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital,Gavimat Campus,Koppal,Karnataka-583231,India 
 
Primary Sponsor  
Name  Dr Akshata Paramagoudar 
Address  Department of Prasooti tantra and Stree Roga,Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital,Gavimat Campus,Koppal,Karnataka-583231,India 
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 
DrAkshata Paramagoudar  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College,Koppal  Department of Prasooti tantra and Stree roga,Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College,Gavi matt campus,Koppal
Koppal
KARNATAKA 
7019017437

paramagoudarakshata@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical college , Koppal  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: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Shrimad Vagbhata,Ashtanga Hridayam,Nirmala hindi commentary by Dr.Brahmanand Tripati,Chaukamba Sanskrit Pratishthan:Delhi;2012,Reprint Edition,Sutra sthana 20th Chapter,Verse 26,27,32,34,35,36;248-249pp., Procedure details: Pratimarsha Nasya,Dose - 2 bindu (approximately - 1ml) in each nostril morning. Duration - After completion of menses, till commencement of next cycle or (Maximum period up to 45 days))
(1) Medicine Name: Arka pushpa Taila, Reference: Vaidhya Lakshmipathi Sastri,Yoga Ratnakara with Vidhyotini Hindi Commentary edited by Bhisagratna Brahmasankar Sastri,Chaukambha Prakashan,Varnasi,Edition:Reprint 2010,Uttarardhaghata Vishayasuchi,Gulmanidhan: (Gulma Chikitsa ),34pp., Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 45 Days
2Comparator ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Shrimad Vagbhata,Ashtanga Hridayam,Nirmala hindi commentary by Dr.Brahmanand Tripati,Chaukamba Sanskrit Pratishthan:Delhi;2012,Reprint Edition,Sutra sthana 20th Chapter,Verse 26,27,32,34,35,36;248-249pp., Procedure details: Pratimarsha Nasya,Dose - 2 bindu (approximately - 1ml) in each nostril morning. Duration - After completion of menses, till commencement of next cycle or (Maximum period up to 45 days))
(1) Medicine Name: Shatapushpa Taila, Reference: P.V.Tewari,Kashyapa samhita or Vrddhajivakiya Tantra Text with English Translation and commentary,Chaukhambha Visvabharati,Varanasi,First edition 1996,Kalpa sthana 5th Chapter,Verse 23,25 348-349pp., Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 45 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Subjects between the age group of 18-35years irrespective of marital life.
Subjects with Pratyatma lakshanas of Artavakshaya-Yatochit kala adarshanam,Alpa artavam,Yoni vedana.
Subjects fulfilling the Rotterdam criteria. 
 
ExclusionCriteria 
Details  Pregnancy and lactating women.
Patients having systemic disorder like Anemia, HTN (uncontrolled),
DM(uncontrolled) & Tuberculosis.
Patients on OCP’s or any other protocol of PCOD treatment.
Patient with congenital uterine abnormalities & ovarian abnormality.
Patient with other pelvic pathologies like genital TB, Benign and Malignant tumours.
Endocrinal disorders – Hyperprolactinemia, Thyroid abnormalities,
Hypo/Hypergonadism and Pituitary Adenoma. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To prevent the reoccurrence of PCOD.  6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To regularise the cycles.  6 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 2 
Date of First Enrollment (India)   28/08/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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  
Menstruation is a physiological process controlled by Hypothalamo - Pituitary – Ovarian Axis and their associated hormones. PCOD has become burning problem in current scenario,due to stressfull lifestyle has a negative impact on neuro endocrine system.PCOD is an heterogeneous disorder ,the incidence varies between 0.5-4%,more common amongst infertile women. It is prevalent in young reproductive age group (20-
30%).Poly Cystic Ovary may be seen in about 20% of normal women. PCOD is an collection of signs and symptoms related to Ovarian Dysfunction, it was originally described by “Stein Leventhal syndrome” it is characterized by an menstrual irregularities, clinical and biochemical Hyperandrogenism and Hyperinsulenemia which ultimately leads to infertility;In modern science scanty, infrequent menstruation are treated by hormonal therapy; long term use of these drug have many limitations so it is very essential to find out effective, non-steroidal, non-hormonal, safe ayurvedic medicine;Our classics suggests both shodhana and shamana line of treatment; Nasya is especially desired for diseases of the parts above the clavicle; nasal passage being the gate way of the head ,permeating through this aperture,this may stimulates the hypothalamus and regulates HPO axis ; the drug suitable for this condition and theraphy is Shatapushpa taila and Arkapushpa taila given in the form of Pratimarsha Nasya.The drug present in formulations of Arkapushpa taila and Shatapushpa taila have properties of Artavajanana; Arkapushpa is having Ushna virya ,katu vipaka, vatakapha hara property it may directly acts on this condition, Tila taila is having Ushna 
virya, Vatahara, Garbhashaya shodana property it may acts on artava pravrutti. Arkapushpa taila is rich in chemical constituents like Flavonoids, Tannins, Carbohydrates,Protiens, Glycosides, Phenols, Steroids and Alkaloids. Tila taila has Madhura vipaka and arkapushpa has Madhura rasa.Madhura rasa has anabolic action which may increases more secretory units and may leads to proper estrogenic effect on endometrium. Due to proper function of receptor mechanism, the ‘Atrava’ may increases in amount.The rasa and virya of the Shatapushpa is Madhura and Ushna respectively, the action of Shatapushpa is balya, brihmaniya, deepana, pachana.yoni - vishodana,rutupravartana etc.“Rutupravartana” indicates both artavajanana and beejotsarga. As per reference of Yogaratnakara and Kashyapa Samhita respectively; are selected for the 
present study; Hence the present study is taken up to evaluate the effect of Arkapushpa Taila in Artavakshaya With Special Reference to PCOD.
 
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