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CTRI Number  CTRI/2024/06/068829 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of Shatapushpa Taila Nasya in two different phases of menstrual cycle in primary dysmenorrhea 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Shatapushpa Taila Nasya in Proliferative and Secretory phases of menstrual cycle in Udavarta Yonivyapat W.S.R. to Primary Dysmenorrhea. 
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 Bhagyavathi S 
Designation  P.G.Scholar 
Affiliation  KVG Ayurveda Medical College and Hospital, 
Address  Room No-1, Panchakarma OPD, KVG Ayurveda Medical college and hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  8748930657  
Fax    
Email  bhagyavathis67@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Soumya S V 
Designation  Professor 
Affiliation  KVG Ayurveda Medical College and Hospital, 
Address  Room No-1,Panchakarma OPD, KVG Ayurveda Medical College and Hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9620283474  
Fax    
Email  drsoumyasv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Soumya S V 
Designation  Professor 
Affiliation  KVG Ayurveda Medical College and Hospital, 
Address  Room No-1,Panchakarma OPD, KVG Ayurveda Medical College and Hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9620283474  
Fax    
Email  drsoumyasv@gmail.com  
 
Source of Monetary or Material Support  
KVG Ayurveda Medical College and Hospital,Ambateadka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada, India- 574327 
 
Primary Sponsor  
Name  Dr Bhagyavathi S 
Address  KVG Ayurveda Medical College and Hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada, India- 574327 
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 Bhagyavathi S  KVG Ayurveda Medical College and Hospital, Sullia  Room No-1, Panchakarma OPD, KVG Ayurveda Medical College and Hospital,Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada- 574327
Dakshina Kannada
KARNATAKA 
8748930657

bhagyavathis67@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Ayurvdea Medical College Ethical Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtanga Hridaya Sutrasthana 20th chapter, Procedure details: Shatapushpa Taila Nasya will be done for a period of 7 days. Poorva Karma- Abhyanga will be done with Murchita Tila Taila to Jatru Urdwa Pradesha followed by Patta Sweda. Pradhana Karma- Patient is asked to lie down on his back extending his arms & legs. The legs should be slightly raised and head in slightly lowered position. The Taila is made lukewarm in water bath, it is taken in Gokarna, and 8 Bindu (4ml) will be instilled into each nostril alternatively, keeping the other nostril closed. Paschat Karma- After instilling Nasya, Mardana is done on his Padatala, Skanda, Hasta and Karna. Patient is made to turn to his sides and asked to spit the secretions with medicine. The patient is made to lie on his back for a Vaak Shata Matra (100 MatraKala) After Nasya Karma, Dhoomapana and Kavala with lukewarm water will be given to the patient.)
(1) Medicine Name: Shatapushpa Taila, Reference: Kashyapa Samhita Kalpa Sthana 5th chapter, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtanga Hridaya Sutrasthana 20th chapter, Procedure details: Shatapushpa Taila Nasya will be done for a period of 7 days. Poorva Karma- Abhyanga will be done with Murchita Tila Taila to Jatru Urdwa Pradesha followed by Patta Sweda. Pradhana Karma- Patient is asked to lie down on his back extending his arms & legs. The legs should be slightly raised and head in slightly lowered position. The Taila is made lukewarm in water bath, it is taken in Gokarna, and 8 Bindu (4ml) will be instilled into each nostril alternatively, keeping the other nostril closed. Paschat Karma- After instilling Nasya, Mardana is done on his Padatala, Skanda, Hasta and Karna. Patient is made to turn to his sides and asked to spit the secretions with medicine. The patient is made to lie on his back for a Vaak Shata Matra (100 MatraKala) After Nasya Karma, Dhoomapana and Kavala with lukewarm water will be given to the patient.)
(1) Medicine Name: Shatapushpa Taila, Reference: Kashyapa Samhita Kalpa Sthana 5th chapter, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Women having the classical Lakshanas of Udavarta Yonivyapat and symptoms of Primary dysmenorrhea.
2. Women who are Nasya Yogya according to Ayurveda Classics irrespective of occupation and socio-economic status.
3. Women in between 12 years and 50 years of age.
 
 
ExclusionCriteria 
Details  1. Women who are Nasya Ayogya according to Ayurveda Classics.
2. Patients with the association of other disorders like fibroid, endometriosis, PID etc.
3. Patients below age of 12 years and above 50 years.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.WaLIDD Score for working ability, intensity of pain, duration of pain asssessment
2. Multidimensional scoring system of dysmenorrhea for assessment of severity of pain, systemic symptoms involved 
0th day, 1st cycle, 2nd cycle, 3rd menstrual cycle after Nasya Karma(Days cannot be specified as the menstrual cycle may varry between 28 to 35 days) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 3 
Date of First Enrollment (India)   01/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhagyavathis67@gmail.com].

  6. For how long will this data be available start date provided 01-07-2024 and end date provided 01-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Ayurveda is accepted as one of the oldest traditional systems of medicine worldwide. In ayurvedic classics, majority of gynaecological disorders have been discussed under Yonivyapat. Udavarta Yonivyapat is one among Vataja Yonivyapat. Due to Nidanas, the Vata Dosha gets vitiated and moved upwards, produces Raja Kruchrena Munjathi (difficult or painful menstruation) and Vedana (Generalised body aches)

Dysmenorrhea is a common menstrual complaint with major impact on women quality of life. The prevalence of dysmenorrhea varies between 16% and 91% in women of reproductive age. Dysmenorrhea means painful menstruation of sufficient magnitude so as to incapacitate day-to-day activities. Primary dysmenorrhea is where there is no pelvic pathology and is caused by psychosomatic factors (tension, stress), increased prostaglandins and vasopressin. Symptoms includes spasmodic pain in lower abdomen, nausea, vomiting, fatigue, diarrhoea, headache. The line of management includes analgesics, antispasmodics, prostaglandins synthetase inhibitors, oral contraceptives and surgery as last resort. These modalities have adverse side effects like dizziness, depression, vertigo, etc. Hence, there is a need to find safe, potent solution for dysmenorrhea.

Vamanadi Karmas like Vamana, Virechana, Anuvasana, Asthapana Basti and Nasya are mentioned as Samanya Chikitsa after proper Snehana and Swedana for all Yonivyapat. As Udavarta Yonivyapat is one among Yonivyapat, the same line of treatment can be considered. Under Panchakarma, Nasya has its action on Shiras as nose is the closest opening for conveying the potency of medicines to cranial cavity, hypothalamus secrets vasopressin and is responsible for expression of pain, stress factors. Thus, Nasya can be considered as a potential treatment modality for dysmenorrhea.

Acharya Kashyapa indicated Shatapushpa Taila Nasya in Vandyatva, which is a type of Vataja Yonivyapat and Udavarta Yonivyapat being a type of Vataja Yonivyapat, Shatapushpa Taila Nasya is considered for the study. Shatapushpa is having properties like Madhura, Balya, Brhmana, Pushti-Varna-Agni Vardhana, Rtupravartana, Yonishukra Vishodana, Ushna and Vatahara. And, Shatapushpa relives dysmenorrhea due to inhibition of prostaglandin production and antispasmodic action.

Luteal-phase human endometrium from dysmenorrheic women has been shown in vitro to produce seven times more prostaglandin F2α than luteal phase endometrium of normal women. So here in this study an attempt is made to compare the efficacy of Shatapushpa Taila Nasya in Proliferative and Secretory phase of menstrual cycle in Udavarta Yonivyapat 
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