| CTRI Number |
CTRI/2025/05/086238 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Shatavari Ghruta in Vandhyatva |
|
Scientific Title of Study
|
Single Arm study for assessment of Shatavari Ghruta in the management of Vandhyatva with special reference to folliiculogenesis in female infertility |
| 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 Sonali Santosh Kerkar |
| Designation |
PG scholar |
| Affiliation |
Dr. G.D. Pol foundation YMT Ayurvedic Medical College |
| Address |
OPD No.26 Prasuti Tantra evum Stree rog Department,Dr.G.D.Pol Foundation,YMT
Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi
Mumbai
Raigarh
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9168356684 |
| Fax |
|
| Email |
sonalikerkar017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Chandrakant Mehere |
| Designation |
Professor and HOD |
| Affiliation |
G. D. Pol Foundation YMT Ayurvedic Medical College |
| Address |
OPD No.26 Prasuti Tantra evum Stree rog Department,Dr.G.D.Pol Foundation,YMT
Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi
Mumbai
Raigarh
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930940403 |
| Fax |
|
| Email |
seema.mehre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Santosh Kerkar |
| Designation |
PG scholar |
| Affiliation |
Dr. G.D.Pol foundation YMT Ayurvedic Medical College |
| Address |
OPD No.26 Prasuti Tantra evum Stree rog Department,Dr.G.D.Pol Foundation,YMT
Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi
Mumbai
Raigarh
MAHARASHTRA
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9168356684 |
| Fax |
|
| Email |
sonalikerkar017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi
Mumbai 410210 |
|
|
Primary Sponsor
|
| Name |
Dr. Sonali Santosh Kerkar |
| Address |
OPD No.26 Prasuti Tantra evum Stree rog Department,Dr.G.D.Pol Foundation,YMT
Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi
Mumbai |
| 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 Sonali Santosh Kerkar |
Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College,Kharghar |
OPD No.26 Prasuti Tantra evum Stree rog Department,Dr.G.D.Pol Foundation,YMT
Ayurvedic Medical College.Institutional Area,Sector 4 Kharghar,Navi
Mumbai
Raigarh
MAHARASHTRA
India 410210
Raigarh
MAHARASHTRA |
9168356684
sonalikerkar017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YMT Ayurvedic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari Ghruta, Reference: vangsen stree garbhotpadan vidhi adhyay shlok no 172-173, Route: Oral, Dosage Form: Ghrita, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: sharkara, madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients with anovulatory cycle
2.Patients with primary and secondary infertility
3.Patients with regular or irregular menses
4.Patients with age 18-35 years |
|
| ExclusionCriteria |
| Details |
1.Congenital anamolies(vaginal, uterus)
2.Ovarian tumours , premature ovarian failure, fibroids,cysts
3.Tubal obstructions
4.Endomtriosis
5.Patient with systemic diseases |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the folliiculogenesis effect of Shatavari Ghruta in Vandhyatva with special reference to in folliiculogenesis in female infertility |
Day 1 to Day 30 (for 3 consecutive cycles) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/04/2026 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The current study aimed as assessment of Shatavari Ghruta in Vandhyatva with special reference to folliculogenesis in female infertility .A single arm open labelled clinical study .Total 45 patients will be taken . Shatavari Ghruta 24ml will be given twice a day for 3 months .A repeat follicular study will be done after 3 months . The purpose of study is to treat infertility in women with decrease or no growth of follicles. |