| CTRI Number |
CTRI/2024/01/061703 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Shatavari oil in female infertility with detoxification by Panchatikta Ghruta |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Shatavari Tail Nasya and Uttarbasti with Snehan and mridu Virechana by Panchatikta Ghruta in Stree Vandhyatva |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANKITA PANDEY |
| Designation |
MS SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDIC PG COLLEGE AND HOSPITAL, VARANASI |
| Address |
Government Ayurveda PG college and Hospital Chaukaghat
Varanasi Uttar Pradesh
Department of Prasuti Tantra evam Stree Roga Government Ayurveda PG college and Hospital Varanasi
Uttar Pradesh
221002
India
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6265220265 |
| Fax |
|
| Email |
pandeya61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjana Saxena |
| Designation |
Reader MD PhD |
| Affiliation |
Government Ayurveda PG college and hospital Varanasi |
| Address |
Department of Prasuti Tantra evam Stree Roga
Government Ayurveda PG college and Hospital Varanasi
Department of Prasuti Tantra evam Stree Roga
Government Ayurveda PG college and Hospital Chaukaghat Varanasi
Varanasi
Uttar Pradesh
221002
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6265220265 |
| Fax |
|
| Email |
dranjana.saxena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANKITA PANDEY |
| Designation |
MS Scholar |
| Affiliation |
Government Ayurveda PG college and hospital Varanasi |
| Address |
Government Ayurveda PG college and Hospital Varanasi
Department of Prasuti Tantra evam Stree Roga
Department of Prasuti Tantra evam Stree Roga
Government Ayurveda PG college and Hospital Chaukaghat Varanasi
Varanasi
Uttar Pradesh
221002
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6265220265 |
| Fax |
|
| Email |
pandeya61@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDIC PG COLLEGE AND HOSPITAL, VARANASI |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT AYURVEDIC PG COLLEGE AND HOSPITAL, VARANASI |
| Address |
DEPARTMENT OF PRASUTI TANTRA EVUM STRI ROGA
GOVERNMENT AYURVEDIC PG COLLEGE, VARANASI |
| Type of Sponsor |
Government 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 Ankita Pandey |
Government Ayurveda PG college and hospital Varanasi |
Department of Prasuti Tantra Evam Stree Roga
Government Ayurveda PG college and hospital Chaukaghat Varanasi
Uttar Pradesh
Varanasi
UTTAR PRADESH |
6265220265
pandeya61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurveda PG college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N979||Female infertility, unspecified. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Kashyap kalpa 5/23-25, Procedure details: Uttar Basti given through vaginal route is started after cessation of menses, for 3 days with increasing doses (3 to 5 ml) for 3 cycles)
(1) Medicine Name: Shatavari Tail, Reference: Kashyap kalpa 5/23-25, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 3 Months | | 2 | Comparator Arm | Procedure | - | nAvanam, नावनमॠ| (Procedure Reference: Kashyap kalpa 5/23-25, Procedure details: Nasya given after cessation of menstrual bleeding for 7 days regularly into both nostrils)
(1) Medicine Name: Shatavari Tail, Reference: Kashyap kalpa 5/23-25, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Married patients of age group 20 to 35 years
All cases of primary and secondary infertility
Male counterparts should be normal
Atleast one fallopian tube must be patent
PCOD
irregular menses
Scanty menses due to anovulatory cycle
Anovulatory cycle
Delayed ovulation |
|
| ExclusionCriteria |
| Details |
Unmarried patients
Age <20 years
Age >35 years
Cervical tumor or polyp
Ca cervix
Uterine fibroid
Congenital anomalies of female genital tract
Tubercular endometritis
HIV/VDRL/HBsAg positive
Malignant disease patients and cytotoxic patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvements in sign and symptoms of Stree Vandhyatva |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve symptoms related to infertility |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "57"
Final Enrollment numbers achieved (India)="57" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2024 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
CONCEPTUAL OVERVIEW OF SHATAVARI TAILA NASYA AND
UTTARABASTI IN MANAGEMENT STREE VANDHYATVA published in World Journal of Pharmaceutical Research Volume 13 Issue 19 413-426
DOI: 10.20959/wjpr202419-34026 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A CLINICAL STUDY TO EVALUATE EFFICACY OF SHATAVARI TAILA NASYA & UTTAR BASTI WITH SNEHAN & MRIDU VIRECHANA BY PANCHATIKTA GHRUTA IN STREE VANDHYATVA.
Total 57 patients are divided into two groups.
Group A 27 patients are treated with nasya.
Group B 30 patients are treated with uttarbasti. |