| CTRI Number |
CTRI/2025/08/093661 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Assess The Action Of Tiladi Ghanavati In Artavakshaya vyadhi, In patients having complaints of less or infrequent menstrual flow and Polycystic Ovarian Morphology (Bulky Ovaries). |
|
Scientific Title of Study
|
An Open Labelled Single Arm Clinical Study To Assess The Role Of Tiladi Ghanavati Orally In Artavakshaya With Special Reference To Polycystic Ovarian Morphology (Bulky Ovaries). |
| 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 Suchita B Rajebhosale |
| Designation |
Assistant Professor |
| Affiliation |
Yashwant Ayurvedic college, Post Graduate Training And Research Centre,Kodoli, |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar,Pune
Department-Prasutitantra-Striroga
OPD Number-12
Yashwant Ayurvedic College,Post Graduate Training and Research Centre, Kodoli.
Department - Prasutitantra- Striroga
Kolhapur
MAHARASHTRA
411028
India |
| Phone |
9112660269 |
| Fax |
|
| Email |
dr.suchita.rajebhosale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita C. Mule |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic college, Post Graduate Training And Research Centre,Kodoli, |
| Address |
Yashwant Ayurvedic college, Post Graduate Training And Research Centre,Kodoli,Tal- Panhala Dist. -Kolhapur.
Department- Prasutitantra-Striroga
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277612 |
| Fax |
|
| Email |
kvt126@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suchita B Rajebhosale |
| Designation |
Assistant Professor |
| Affiliation |
Yashwant Ayurvedic college, Post Graduate Training And Research Centre,Kodoli, |
| Address |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar,Pune
Department - Prsutitantra - Striroga.
OPD Number - 12
Kolhapur
MAHARASHTRA
411028
India |
| Phone |
9112660269 |
| Fax |
|
| Email |
dr.suchita.rajebhosale@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai Shah Ayurved Mahavidyalays ,Sane Guruji Arogya Kendra, Hadapsar,Tal-Haveli, Dist - Pune, Country - India.
PIN Code - 411028. |
|
|
Primary Sponsor
|
| Name |
Dr Suchita B Rajebhosale |
| Address |
MAMs Sumatibhai Shah Ayurved MAhavidyalaya, Hadapsar,Pune - 411028 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suchita Baburao Rajebhosale |
Sane Guruji Hospital of Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar,Pune |
Department of Prasutitantra striroga
OPD Number -12
Pune
MAHARASHTRA |
9112660269
dr.suchita.rajebhosale@gmail.com |
| Dr Suchita Baburao Rajebhosale |
Yashwant Dharmarth Rugnalaya of Yashwant Ayurvedic college Post Graduate and Research Centre,kodoli |
Department of Prasutitantra striroga
Pune
MAHARASHTRA |
9112660269
dr.suchita.rajebhosale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
| Institutional Ethics Committee |
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 | Drug | Classical | | (1) Medicine Name: Tiladi Ghanavati, Reference: Gadnigrah Pradar- Pushpa utapatti Pushpanash Adhyay 56, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
a.Patients suffering from 1 or more typical Lakshanas of Artavakshaya (Oligomenorrhea, Hypomenorrhea) and with Polycystic Ovarian Morphology (Bulky Ovaries).
b.Patients having scanty menses having menstrual flow less than 3 days as compared to previous menses. |
|
| ExclusionCriteria |
| Details |
a.Patient with operable organic, congenital or acquired defect in female genital tract.
b.Patients taking oral contraceptive pills or taking Contraceptive Injectable and having IUCD’s, etc.
c.Patients taking anti-depressant therapy.
d.Patients having systemic disease like DM, HTN, Anemia, HIV, HBsAg, VDRL, Tuberculosis.
e.Uterine fibroid, Complex ovarian cyst, Dermoid cyst, Tubo ovarian mass.
f.Patients with Hormonal imbalance.
g.Patients suffering from uterine Synechiae (Intrauterine adhesions/ Asherman), Malignancy, Endometriosis.
h.Pregnancy, lactating and post-natal and perimenopausal female.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study The Role Of Tiladi Ghanvati in Atavakshaya with Special Reference to Polycystic Ovarian Morphology (Bulky Ovaries). |
To Study The Role Of Tiladi Ghanvati in Atavakshaya with Special Reference to Polycystic Ovarian Morphology (Bulky Ovaries). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study Polycystic Ovarian Morphology (Bulky Ovaries) in detail.
2)To study the adverse effect of Tiladi Ghanavati which can be occurred during study.
3)To study Artavakshaya in detail.
4)To study role of Tiladi Ghanavati in Artavakshaya in 3 months.
|
During The Study Period. |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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 Yet Recruiting |
| 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
|
TITLE - An Open Labelled Single Arm Clinical Study to Assess the Roll of Tiladi Ghanavati Orally In Artavakshaya with Special Reference to Polycystic Ovarian Morphology (Bulky Ovaries). Methodology - 1. Type of study design - Single arm clinical study. 2. Study population– Diagnosed Patients of Artavakshaya with special reference to Polycystic Ovarian Morphology (Bulky Ovaries). 3. Method Of Sample Selection-Sequential Sampling. 4. Sample Size – 87 5. Duration of study –Duration of study will be approx. 18 months 6. Inclusion criteria– a. Patients suffering from1or more typical Lakshanas of Artavakshaya (Oligomenorrhea, Hypomenorrhea) and with Polycystic Ovarian Morphology (Bulky Ovaries). b. Patients of age group 20-35 years. c. Patient selection will be irrespective of marital status, parity and dosh prakruti. d. Patients having scanty menses having menstrual flow less than 3 days as compared to previous menses. e. Patients ready for clinical trial. 7. Exclusion criteria– a. Patient with operable organic, congenital or acquired defect in female genital tract. b. Patients taking oral contraceptive pills or taking Contraceptive Injectable and having IUCD’s, etc. c. Patients taking anti-depressant therapy. d. Patients having systemic disease like DM, HTN, Anemia, HIV, HBsAg, VDRL, Tuberculosis. e. Uterine fibroid, Complex ovarian cyst, Dermoid cyst, Tuboovarian mass. f. Patients with Hormonal imbalance. g. Patients suffering from uterine Synechiae (Intrauterine adhesions or Asherman), Malignancy, Endometriosis. h. Pregnancy, lactating and post-natal and perimenopausal female. 8. Withdrawal criteria – a. If patient develop any adverse effect. b. If aggregation of symptoms occurs. c. If patient refuses to continue the treatment. d. If patient never comes for follow up. e. Patients who are taking irregular medication. |