| CTRI Number |
CTRI/2025/03/083667 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare between the effect of pippalyadi ghrita and shatapushpa taila as pratimarsha nasya in the management of Infertility |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of pippalyadi ghrita and shatpushpa taila in the form of pratimarsha nasya in vandhyatwa (anovulation) |
| 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 Prerna Atul Nalode |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Koppal. |
| Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital department of Prasuti tantra and stree roga Koppal
Koppal
KARNATAKA
583231
India |
| Phone |
9403377206 |
| Fax |
|
| Email |
prernanalode96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niveditha Somalapur |
| Designation |
Associate proffessor |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital |
| Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Prasuti tantra and Stree roga Koppal
Koppal
KARNATAKA
583231
India |
| Phone |
9886800413 |
| Fax |
|
| Email |
nivedita.somalapur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niveditha Somalapur |
| Designation |
Associate proffessor |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital |
| Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Prasuti tantra and Stree roga Koppal
KARNATAKA
583231
India |
| Phone |
9886800413 |
| Fax |
|
| Email |
nivedita.somalapur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Prasuti tantra and Stree roga Koppal Pin code 583231 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Prerna Atul Nalode |
| Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Prasuti tantra and Stree roga Koppal |
| 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 Prerna Atul Nalode |
Department of Prasuti tantra and Stree roga |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Koppal.
Koppal
KARNATAKA |
9403377206
prernanalode96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hrudaya sutrasthana 20, Procedure details: Dose 2 drops approx.0.1-0.2ml in each nostril morning. duration from 6day to 25 day of menstruation for 2 cycles)
(1) Medicine Name: Pippalyadi ghrita, Reference: Bhaishajya ratnavali adhyaya 67 yonivyapad chikitsa, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 2 Months | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hrudaya sutrasthana 20, Procedure details: Dose 2 drops approx.0.1-0.2ml in each nostril morning. duration from 6day to 25 day of menstruation for 2 cycles)
(1) Medicine Name: Shatapushpa taila, Reference: Kahyapa samhita kalpa sthana shatapushpa shatavari adhyaya, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Married woman between 20 to 35 years
infertility associated with anovulatory cycles
functional PCOS
dysfunctional uterine bleeding
|
|
| ExclusionCriteria |
| Details |
Congenital anamolies of reproductive organs
abnormal uterine bleeding
systemic diseases like DM HTN hypothyroidism hyperthyroidism STDs HIV HbsAg |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access the efficacy of pippalyadi ghrita pratimarsh nasya in anovulatory cycle to induce ovulation |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of shatapushpa taila and pippalyadi ghrita pratimarsha nasya in anovulatory cycle to induce ovulation.
to regularise the cycle and to increase fertility rate |
6 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)
|
07/04/2025 |
| 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="0"
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
|
This is a randomized controlled clinical study to evaluate the efficacy of Pippalyadi ghrita and Shatapushpa taila in the form of pratimarsh nasya in 40 patients diagnosed with vandhyatwa (Anovulation) to induce ovulation for 2 cycyles (months) that will be conducted in India the primary outcome is to access the efficacy of pippalyadi ghrita pratimarsh nasya in anovulatory cycle to induce ovulation the secondary outcome is to to compare the efficacy of shatapushpa taila and pippalyadi ghrita pratimarsha nasya in anovulatory cycle to induce ovulation and
to regularise the cycle and to increase fertility rate |