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CTRI Number  CTRI/2023/08/056441 [Registered on: 11/08/2023] Trial Registered Prospectively
Last Modified On: 03/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Pratimarsha Nasya With Shatapushpa Taila And Tila Taila In Oligomenorrhea. 
Scientific Title of Study   A Randomized Open Labeled Comparative Clinical Study To Evaluate The Efficacy Of Pratimarsha Nasya With Shatapushpa Taila And Tila Taila In Artava Kshaya w.s.r. To Oligomenorrhea 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Netra Karjagi 
Designation  PG Scholar 
Affiliation  Sri Sri College Of Ayurvedic Science And Research Hospital 
Address  Sri Sri College Of Ayurvedic Science And Research Hospital Department Of Prasuti Tantra And Stree Roga OPD no 10,21st Km Kanakapura Road Udayapura Post Bengaluru Karnataka

Bangalore
KARNATAKA
560082
India 
Phone  7204978431  
Fax    
Email  netratkarjagi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Savita S Patil 
Designation  Professor and HOD 
Affiliation  Sri Sri College Of Ayurvedic Science And Research Hospital 
Address  Sri Sri College Of Ayurvedic Science And Research Hospital Department Of Prasuti Tantra And Stree Roga OPD no 10,21st Km Kanakapura Road Udayapura Post Bengaluru Karnataka

Bangalore
KARNATAKA
560082
India 
Phone  9742193553  
Fax    
Email  rampursspatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Savita S Patil 
Designation  Professor and HOD 
Affiliation  Sri Sri College Of Ayurvedic Science And Research Hospital  
Address  Sri Sri College Of Ayurvedic Science And Research Hospital Department Of Prasuti Tantra And Stree Roga OPD no 10,21st Km Kanakapura Road Udayapura

Bangalore
KARNATAKA
560082
India 
Phone  9742193553  
Fax    
Email  rampursspatil@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College Of Ayurvedic Science And Research Hospital,Bengaluru-560082 
 
Primary Sponsor  
Name  Dr Netra Karjagi 
Address  Sri Sri Ayurvedic Science And Research Hospital,21st Km Kanakapura Road Udayapura Post Bengaluru 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 Netra Karjagi  Sri Sri College of Ayurvedic Science and Research  OPD no 10, department of PG studies in Prasuti Tantra and Streeroga, 21st KM, Kanakapura road,Udayapura post Bangalore Karnataka
Bangalore
KARNATAKA 		 07204978431

netratkarjagi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Kashyapa Samhita Kalpastana, Procedure details: In Rutukala that is after the menstrual flow stops from 7th days (after complete stoppage of bleeding) continuously for 21days of cycle. 2 drops have to be instilled in each nostril. )
(1) Medicine Name: Shatapushpa , Reference: Kashyapa Samhita Kalpastana, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 21 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Kashyapa Samhita Kalpastana, Procedure details: In Rutukala that is after the menstrual flow stops from 7th days (after complete stoppage of bleeding) continuously for 21days of cycle. 2 drops have to be instilled each nostril. )
(1) Medicine Name: Tila taila, Reference: Sushruta Samhita Sutrastana , Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Subjects of age group between 18 years to 40 years.
2.Both married and unmarried women.
3.Subjects presenting with classical symptoms of Artava Kshaya.
4.Subjects presenting with symptoms of Oligomenorrhea.
5.Subjects with Poly Cystic Ovaries
 
 
ExclusionCriteria 
Details  1.Subjects with history of PID, Tuberculosis, Pelvic Endometriosis, Adenomyosis.
2.Subjects with known cases of Hypertension, Thyroid disorders, Anemia.
3.Subjects with any known case of Benign and Malignant tumors.
4.Subjects with Congenital Anomalies.
5.Nasya Ayogya 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in flow of menstrual bleeding, Interval between 2 cycles  Before treatment 0th day
after treatment - after subjects gets her cycle 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of pain during menstruation, number of pads.  0th Day ,After subject gets her cycle (Maximum study duration 42 days) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   24/08/2023 
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)   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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [netratkarjagi@gmail.com].

  6. For how long will this data be available start date provided 15-04-2025 and end date provided 17-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
  • Streeroga includes an array of diseases, among which Artava Dushti indicates menstrual disorders. The ultimate effect of Artava Vyapath is Abeejatva, diagnosis and treatment of Artava Vyapath is essential
  •    Artava Kshaya is a condition in which menstruation fails to occur at appropriate time (delayed) with scanty flow and does not last for 3 days.3
  • A similar entity in contemporary science, where menstrual bleeding occurring more than 35 days apart and which remains constant at the frequency is called oligomenorrhea.
  • The treatment opted in modern system of medicine is hormonal therapy, which may have adverse effect on body like obesity, nausea, vomiting, endometrial cancer and breast cancer.
  • Acharya says “Nasa Hi Shiraso Dwaram” i.e. Nasa is said to be the door of Shiras because Nasa is indirectly connected with the brain centers in the head.
  • As Nasya helps in regulating hypothalamus where GnRH is produced and is also connected with pituitary gland which produces hormones like FSH, LH, estrogen, progesterone and prolactin thus resulting in regulation of HPO axis.
  • Nasya is very convenient to the patients due to its easy procedure and less requirement of time. Hence Shatapushpa Taila and Tila Taila Nasya is expecting to benificial results in Artavakshaya and hence taken for the study.

 
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