| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm | Procedure | - | 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. |