| CTRI Number |
CTRI/2023/08/056245 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
07/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate efficacy of Traditional Ayurvedic Formulation (Divya Santati Sudha) in female infertility. |
|
Scientific Title of Study
|
To evaluate efficacy of Traditional Ayurvedic Formulation (Divya Santati Sudha) in female infertility: an observational, single-arm, prospective study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devika Balagopalan |
| Designation |
Clinical Research Associate |
| Affiliation |
Patanjali Research Institute |
| Address |
Patanjali Research Institute, Opp. Patanjali Yogpeeth-1, Maharishi
Dayanand Gram, Delhi-Haridwar National Highway, Near
Bahadrabad, Haridwar, Uttarakhand, India- 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7293549081 |
| Fax |
|
| Email |
drvika.balagopalan@patanjali.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devika Balagopalan |
| Designation |
Clinical Research Associate |
| Affiliation |
Patanjali Research Institute |
| Address |
Patanjali Research Institute, Opp. Patanjali Yogpeeth-1, Maharishi
Dayanand Gram, Delhi-Haridwar National Highway, Near
Bahadrabad, Haridwar, Uttarakhand, India- 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7293549081 |
| Fax |
|
| Email |
drvika.balagopalan@patanjali.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devika Balagopalan |
| Designation |
Clinical Research Associate |
| Affiliation |
Patanjali Research Institute |
| Address |
Patanjali Research Institute, Opp. Patanjali Yogpeeth-1, Maharishi
Dayanand Gram, Delhi-Haridwar National Highway, Near
Bahadrabad, Haridwar, Uttarakhand, India- 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7293549081 |
| Fax |
|
| Email |
drvika.balagopalan@patanjali.res.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Institute governed by Patanjali Research Foundation Trust |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Institute governed by Patanjali Research Foundation Trust |
| Address |
Opp. Patanjali Yogpeeth-1, Maharishi Dayanand Gram,
Delhi-Haridwar National Highway, Near Bahadrabad, Haridwar,
Uttarakhand, India- 249405 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devika Balagopalan |
Patanjali Wellness Center |
Panchkarma, Patanjali Wellness, Patanjali Yogpeeth Phase-2, Delhi-Haridwar National Highway, Haridwar, Uttarakhand, India- 249405.
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
7293549081
devika.balagopalan@patanjali.res.in |
| Dr Devika Balagopalan |
Patanjali Yoggram |
Yog Naturopathy Panchkarma, Patanjali Yoggram, Village Aurangabad, Near SIDCUL Roshnabad, Haridwar, Uttarakhand, India- 249402
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
7293549081
devika.balagopalan@patanjali.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Divya Santati Sudha, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 540(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Clinically diagnosed with Primary or secondary infertility.
2. Availability and willingness to provide consent.
|
|
| ExclusionCriteria |
| Details |
1. Patient known to have any Malignancies, chronic Hyper/hypothyroidism.
2. Patient diagnosed with congenital uterine defects.
3. Male partner with abnormal seminal analysis and unwillingness to get treated.
4. Participant habituated to alcohol consumption, smoking or any other substance abuse.
5. The subjects not willing to provide consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of the life and problem related infertility of the subject by the help of Fertility quality of life (FertiQoL) and The fertility problem inventory. |
Baseline, 30 day, 60 day and 90 day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the quality of the life and problem related infertility of the subject by the help of Fertility quality of life (FertiQoL) and The fertility problem inventory. |
Baseline, 30 day, 60 day and 90 day. |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
31/08/2023 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is single-arm, open-label, Prospective study and observational study. Eligible patients will receive 540 mg of Divya Santati Sudha tablet as per prescribed by Ayurvedic practitioner. The outcomes will be to evaluate the efficacy and safety of Divya-Santati-Sudha Tablet (Traditional Indian Ayurvedic Medicine) in patients with infertility and to assess the quality of the life and problem related infertility of the subject by the help of Fertility quality of life (FertiQoL) and The fertility problem inventory. |