| CTRI Number |
CTRI/2022/09/045234 [Registered on: 06/09/2022] Trial Registered Prospectively |
| Last Modified On: |
01/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Shivlingi Beej and Narayan Taila Uttar basti in female infertility |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHIVLINGI BEEJ AND NARAYAN TAILA UTTAR BASTI IN VANDHYATVA W.S.R. TO ANOVULATION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Shukla |
| Designation |
HOD, Department of Prasuti Tantra avum Stree Roga |
| Affiliation |
RGGPG Ayurvedic college and Hospital, Paprola |
| Address |
Room no. 203, Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic college and Hospital, Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Shukla |
| Designation |
HOD, Department of Prasuti Tantra avum Stree Roga |
| Affiliation |
RGGPG Ayurvedic college and Hospital, Paprola |
| Address |
Room no. 203, Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic college and Hospital, Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Rana |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic college and Hospital, Paprola |
| Address |
Room no. 804, Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic college and Hospital, Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8091179796 |
| Fax |
|
| Email |
rana.pratibha123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic college and Hospital |
| ISM, Jogindernagar |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
Principal Room, Admin Block, RGGPG Ayurvedic college and Hospital, Paprola |
| 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 Seema Shukla |
RGGPG Ayurvedic college and Hospital, Paprola |
OPD and IPD of
Department of Prasuti
Tantra evum Stree
Roga, RGGPG
Ayurvedic College and
Hospital, Paprola
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9418008833
drseemanil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human), RGGPG Ayurvedic College and Hospital, Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E289||Ovarian dysfunction, unspecified. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Letrozole | Letrozole
2.5 mg on 3rd day of cycle for 5 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shivlingi Beej, Reference: Anukat Dravya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: -(2) Medicine Name: Dasmula Trivrita, Reference: Ashtang Samgrah Sutar Sthana 39/29, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 960(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: Dasmula Trivrita Asthapan Basti 960 ml for 3 consecutive days after the clearance of period(3) Medicine Name: Narayan Taila, Reference: Sharangdhar Samhita Madhyakhand 9, Route: Vaginal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: Narayan Taila Utar Basti 3 ml for 3 consecutive days after 3 days of Dashmula Trivrita Asthapan Basti |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
History of infertility for more than 1 year.
All cases of primary & secondary infertility.
Fallopian tubes should be patent.
Sperm analysis of male counterpart should be normal in all aspects.
Patient ready for trial after written consent.
Patient of age group 20-35 years. |
|
| ExclusionCriteria |
| Details |
1.Female less than 20 years and more than 35 years of age.
2.Infertility due to abnormality in male partner.
3.Bilateral tubal blockage.
4.Reproductive tract abnormalities like cervical stenosis, cervical polyps, fibroid uterus.
5.Congenital anatomical deformities such as bicornuate uterus etc.
6.Patient suffering from diseases such as diabetes mellitus, cardiac disorders, tuberculosis, renal disorders, bronchial asthma.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ovulation |
3 months after intervention of drugs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fertility |
2 months after ovulation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research report will be soon published after the completion of trial. 30 patients fulfilling the inclusion and exclusion criteria will be randomly selected from OPD and IPD of Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola. Patients will be divided randomly into 2 groups; Group I and Group II each with 15 patients. Group I will be given Shivlingi Beej 1 gm BD for 3 months, Dasmula Trivrita Asthapan Basti for 3 consecutive days after clearance of period followed by Narayan Taila Uttar Basti for 3 consecutive days after 3 days of Dasmula Trivrita Asthapan Basti. Group II includes the patients managed with clomipene citrate 50 mg on 3rd day of cycle for 5 days. Result will be assessed on the basis of subjective and objective assessment criteria. |