| CTRI Number |
CTRI/2025/02/080912 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of Nagkesaradi Yog in Anovulatory Cycles. |
|
Scientific Title of Study
|
A Single Arm Open Labelled Clinical study to evaluate the efficacy of
Nagkesaradi Yog in Anovulatory Cycles. |
| 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 Sana Shaikh |
| Designation |
PG Scholar |
| Affiliation |
YMT Ayurvedic Medical College and Hospital |
| Address |
3rd floor, Gynaecology Department, YMT Ayurved Medical College, Sector - 4, Kharghar, Navi Mumbai - 410210
3rd floor, Gynaecology Department, YMT Ayurved Medical College, Sector - 4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
08652152457 |
| Fax |
|
| Email |
Sanaashaikh35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jeny Bhatt |
| Designation |
PG Guide |
| Affiliation |
YMT Ayurvedic Medical College and Hospital |
| Address |
3rd floor, Gynaecology Department, YMT Ayurved Medical College, Sector - 4, Kharghar, Navi Mumbai - 410210
3rd floor, Gynaecology Department, YMT Ayurved Medical College, Sector - 4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9167541086 |
| Fax |
|
| Email |
dr.jenybhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sana Shaikh |
| Designation |
PG Scholar |
| Affiliation |
YMT Ayurvedic Medical College and Hospital |
| Address |
3rd floor, Gynaecology Department, YMT Ayurved Medical College, Sector - 4, Kharghar, Navi Mumbai - 410210
3rd floor, Gynaecology Department, YMT Ayurved Medical College, Sector - 4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
08652152457 |
| Fax |
|
| Email |
Sanaashaikh35@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Ayurved Medical College, 3rd floor, Gynaecology Department,Sector - 4, Kharghar, Navi Mumbai - 410210 |
|
|
Primary Sponsor
|
| Name |
YMT Ayurved Medical College Hospital |
| Address |
3rd floor, Gynaecology Department, Sector - 4, Kharghar, Navi Mumbai - 410210 |
| Type of Sponsor |
Private medical college |
|
|
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 Sana Shaikh |
YMT Ayurved Medical College and Hospital |
3rd floor, Gynaecology Department, Sector - 4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA |
8652152457
sanaashaikh35@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: Nagkesaradi Yog, Reference: Vangsen, stree, garbhotpadan vidhi adhyay, shlok no 145, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 12 Days, anupAna/sahapAna: Yes(details: water), Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with Primary and Secondary Infertility with Anovulatory cycles.
2. Patients having regular and irregular menses.
3. Patient with PCOS.
|
|
| ExclusionCriteria |
| Details |
1. Congenital anomalies (vaginal, uterine, ovarian).
2. Ovarian Tumor, Fibroids, Premature ovarian failure.
3. Patients with known case of systemic diseases like DM, Hypothyroidism and
Hyperthyroidism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Nagkesaradi Yog in Anovulatory Cycles. |
Time at which the outcome will be assessed/estimated i.e. at baseline, 4 weeks, 8 weeks & 12 weeks. |
|
|
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 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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
|
It is a single arm open labelled clinical study, 45 patients will be taken, nagkesaradi yog will be given in 3 gms , once a day, starting from 5th day of menses for 12 days. evaluation will be done on basis of ovulation seen in follicular study. at 4 weeks, 8 weeks & 12 weeks. After every menses from 8th day of menses we will start follicular study every alternate day & rupture / ovulation will be checked. purpose of study- the purpose of this study is to treat infertility in women with anovulatory cycles.
|