| CTRI Number |
CTRI/2025/04/085466 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Pippalyadi Churna in Female Infertility. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Study The Effect Of Pippalyadi Churna In Stree Vandhyatva With Special Reference To Anovulatory Cycle |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shafaq Zahra Ansari |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur |
| Address |
OPD NO 5 Prasutitantra and Streeroga Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9579842780 |
| Fax |
|
| Email |
shafaqzahra0808@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemalata Chandrashekhar Kongi |
| Designation |
HOD |
| Affiliation |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur |
| Address |
OPD NO 5 Prasutitantra and Streeroga Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9225347295 |
| Fax |
|
| Email |
drkongihema@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemalata Chandrashekhar Kongi |
| Designation |
HOD |
| Affiliation |
LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur |
| Address |
OPD NO 5 Prasutitantra and Streeroga Department LRP Ayurvedic Medical College and Hospital PG Institute and Research Center Urun Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9225347295 |
| Fax |
|
| Email |
drkongihema@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic Medical college Hospital Post Graduate Institute and Research Center Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Shafaq Zahra Ansari |
| Address |
OPD NO 5 Prasutitantra and Streeroga Department LRP Ayurvedic Medical college Hospital Post Graduate Institute and Research Center Islampur Tl Walwa District Sangli Maharashtra India 415409 |
| 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 Shafaq Zahra Ansari |
LRP Ayurvedic Medical college Hospital Post Graduate Institute and Research Center Islampur |
OPD no 5 Prasutitantra and Streeroga Department LRP Ayurvedic Medical college and Hospital Post Graduate Institute and Research Center Islampur 415409
Sangli
MAHARASHTRA |
09579842780
shafaqzahra0808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee LRP Ayurvedic Medical college and Hospital and PCT and RC Approved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi Churna, Reference: Bharat Bhaiyshajya Ratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -ghrita), Additional Information: -14 days from 5th to 18th day of Menses for 2 consecutive cycles. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatapushpa churna, Reference: Kashyap Samhita, Kalpasthan, Ch 5/17,18, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Ghrita), Additional Information: -14 days from 5th to 18th day of menses for 3 consecutive cycles. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Diagnosed married female patients fulfilling criteria of Stree Vandhyatva of age group 18 to 35 years.
2 Patients having regular mensturation.
3 Patients having complaints of failure to conceive due to Anovulatory cycle.
4 Primary and secondary type of infertile patient will be taken for study |
|
| ExclusionCriteria |
| Details |
1 Patients having physiological anovulatory conditions like pregnancy lactation and menopause.
2 Patients suffering from known chronic illness, cardiac disease and known case of thyroidism.
3 Patients having Abnormal Uterine Bleeding, cervical tumor, polyp cancer of cervix, uterine fibroid.
4 Known case of congenital anomalies of female genital organ like infantile uterus and absence of ovaries. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study Effect Of Pipplyadi Churna in Stree Vandhyatva with special refference to Anovulatory Cycle |
14 days from Day 5th to Day 18th of Menses for 2 consecutive cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study Stree Vandhyatva according to Ayurveda.
2. To study female Infertility with special reference to Anovulation in detail
according to modern science.
3. To study Pippalyadi Churna in detail. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/05/2025 |
| 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 or inability to produce a fertile ovum is an important reason among woman facing infertility and still it is a growing problem due to changing life style, faulty food habits, environment, stress provoking jobs. In such patients ovulation induction is a rescuer. Over the past few decades modern medical field developed modalities like Clomid Therapy, Letrozole, Insulin sensitizing drugs, Ovarian drilling, HCG injections, Gonadotropin therapy but all these modalities are associated with many complications like Ovarian Hyperstimulation Syndrome (OHSS), Multiple Pregnancy etc. Considering all these drawbacks an appropriate management of anovulation is required. In Ayurveda, Anovulation is quoted as the result of vitiation of doshas in reproductive system of a woman suffering from menstrual disorders. Vata dosha is controller of any type of movement in the body and regeneration and growth are facilitated by Kapha. Lower part of the body is seat of Vata. When Vata is vitiated by its aggravating factors or vitiated due to the occlusion or obstruction by Kapha it cannot govern its normal functions and anovulation state persists. Among the three doshas, Vata plays major role in physiology and pathology of reproductive tract and the drug which is fruitful in Agnimandhya i.e deepana & pachana may also be useful for anovulation. Anovulation is mainly related to Rasavaha and Artavaha strotas, according to Samprapti of Nastabeej there is a sanga type of strotodusti due to dosha dushya sammurchhana. Pippalayadi Churna has mainly ushna virya which remove strotorodha and increase the secretion of endometrial glands by opening the vessels, Keeping this hypothesis in mind it is planned to evaluate the effect of Pippalyadi Churna in Anovulatory factor of infertility. |