| CTRI Number |
CTRI/2025/05/086642 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessing Impact Of Shatapushpadi Taila And Phalaghrita Nasal Instillation In Treating Women With Ovulation Problem |
|
Scientific Title of Study
|
Effect of Shatapushpadi Taila and Phalaghrita Nasya in Anovulation-An open label comparative clinical study |
| 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 Suma Patil |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
Opd Number 9, Department Of Prasuti Tantra And Stree Roga,JSS Ayurveda Medical College And Hospital,
41/E,Lalithadripura Road, Alanahalli,Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
8152863616 |
| Fax |
|
| Email |
sumapatil136@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seemantini D Yalagudri |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
Department Of Prasuti Tantra And Stree Roga,
41/E,Lalithadripura road, Alanahalli,Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
7349496230 |
| Fax |
|
| Email |
seemantinij@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seemantini D Yalagudri |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
Department Of Prasuti Tantra And Stree Roga,
41/E, Lalithadripura Road, Alanahalli, Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
7349496230 |
| Fax |
|
| Email |
seemantinij@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College And Hospital, Mysuru, Karnataka, 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Suma Patil |
| Address |
OPD NO 9, Department of Prasuti tantra and stree roga, JSS Ayurveda Medical College And Hospital,
41/E, Lalithadripura road, Alanahalli, Mysuru-570028, Karnataka,India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS Ayurveda Medical College And Hospital |
41/E, Lalithadripura road, Alanahalli, Mysuru-570028 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suma Patil |
JSS Ayurveda Medical College And Hospital |
Opd Number 9, Department Of PG Studies In Prasuti Tantra And Stree Roga,
41/E, Lalithadripura road, Alanahalli, Mysuru
Mysore
KARNATAKA |
8152863616
sumapatil136@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, JSS Ayurveda Medical College, Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E288||Other ovarian dysfunction. Ayurveda Condition: GRANTHIBUTA-ARTAVADUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Charaka Samhita Siddhi Sthana 9 th Chapter, Shloka Number 98-106, Procedure details: Poorva Karma - Mukha Abhyanga With Ksheerabala Taila Followed By Mukha Bashpa Sweda Pradhana Karma -Instillation Of Phalaghrita In Each Nostril Paschatkarma- Kavala With Sukoshna Jala, Doomapana With Haridravarti)
(1) Medicine Name: Phalaghrita, Reference: Ashtanga Hridhaya Uttara Sthana, 34th Chapter, Shloka Number 63-67, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Charaka Samhita Siddhi Sthana 9 th Chapter, Shloka Number 98-106, Procedure details: Poorva Karma - Mukha Abhyanga With Ksheerabala Taila Followed By Mukha Bashpa Sweda
Pradhana Karma -Instillation Of Shatapushpadi Taila In Each Nostril
Paschatkarma- Kavala With Sukoshna Jala, Doomapana With Haridravarti
)
(1) Medicine Name: Shatapushpadi Taila, Reference: Kashyapa Samhita, Revati Kalpa Adhyaya, Shloka Number 23-25, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Complain of irregular cycles.
2.K/C/O PCOS.
3.Subjects fulfilling the diagnostic criteria.
4.Age group - from 18 to 35 years.Subjects who are
fit for Nasya karma. |
|
| ExclusionCriteria |
| Details |
1. Known case of chronic illness like cardiac diseases, thyroid dysfunction and
diabetes mellitus, chronic rhinitis and sinusitis.
2. Known case of Pelvic inflammatory disease, benign and malignant lesions of
reproductive organs, tuberculosis of reproductive organs.
3. Congenital deformities of female reproductive system.
4. Patients who are under treatment like oral contraceptives/steroids, emergency pills
or any reproductive hormones. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Shatapushpadi Taila and Phala Ghrita Nasya in
Anovulation |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Shatapushpadi Taila Nasya in Anovulation.
To evaluate the effect of Phala Ghrita Nasya in Anovulation. |
3 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 3 |
|
Date of First Enrollment (India)
|
19/05/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Anovulation condition is one among the ovulatory dysfunction . Approximately 75% of anovulatoy women of any cause have polycystic ovaries and 20- 50% women with normal ovulation demonstrate ultrasound findings typical of polycystic ovaries.When compared with levels found in normal women, patients with persistent anovulation have higher mean concentration of LH but low or low normal levels of FSH.The characteristics feature of anovulation in PCOS is the arrest of growth of antral follicles after reaching a diameter between 5-8mm. Because of low FSH follicular growth arrested at different phases of menstruation and because elevated level of LH there will be hypertrophy of theca cells and more production of androgens from theca or stroma cells, hence ovulation cannot occur . In Ayurveda classics there are no direct references available for this disease,but many scattered references are available in different samhita. Acharya Sushrutha quotes artavakshaya lakshanas in Doshadhatumalakshayavriddhi adhyaya ,they are Yathochitkala adarshana(irregular), alpadarshana (scanty flow) . Nastabeejartava is caused by vitiation of Vata and Kapha,which impairs the Uttarottaradhatu Vridhi resulting in Rasa Kshaya, this affects the Artava Utpatti which is an Upadhatu,due to impaired Kapha does Avarana which results in anovulation. Ovulation induction is the first line of treatment for the Anovulation. There are number of drugs are used for ovulation induction but they are reported to have various adverse effects,such as Ovarian hyper stimulation syndrome,Ovarian enlargement,Ovarian cancer,Ectopic pregnancy,Premature delivery,nausea, vomiting,breast tenderness,headache etc. Hence there is a need to find some safe and effective drug for ovulation. So as for Shatapushpadi taila many studies are conducted in the form of Basti,Pana,Nasya in vandhyatwa,PCOS,Artavakshaya and Anartava,because Shatapushpadi taila has qualities like Rutupravartaka, Yonishukravishodha, Putraprada and Deepana, Pachana. And for Phala ghrita the research studies were conduted in the form of Snehapana, Uttarabasti Vandyatwa / female infertility ,development of ovarian follicle . Phala ghrita possess the properties like Yonishukradoshahara,Ayushya,Medhya,Pushti.Therefore the drugs selected for this study are Shatapushpadi taila and Phala ghrita for Nasya. |