| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (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 | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (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 |
|
|
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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.
|
|
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhagyavathis67@gmail.com].
- 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.
- 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 |