| CTRI Number |
CTRI/2017/03/008067 [Registered on: 14/03/2017] Trial Registered Prospectively |
| Last Modified On: |
10/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Pilot Clinical study of Siddha Medicine in the treatment of Pen Maladu (Female Infertility) |
|
Scientific Title of Study
|
A Pilot Clinical study to evaluate the therapeutic efficacy of the Siddha formulation of Siddhathi Ennai and Vediuppu Chunnam in Pen maladu (Female infertility) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Yavanarani |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhandai Maruthuvam
National Institute of Siddha Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
944891147 |
| Fax |
04422381314 |
| Email |
dr.yavana25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Meenakshisundaram |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhandai Maruthuvam
National Institute of Siddha Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@radiffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Meenakshisundaram |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhandai Maruthuvam
National Institute of Siddha Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@radiffmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram sanatorium
Chennai 600047
Kancheepuram District Tamilnadu |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Tambaram sanatorium
Chennai 600047
Kancheepuram District
Tamilnadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S Yavanarani |
National Institute of Siddha |
Department of Kuzhandai Maruthuvam
National Institute of Siddha Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU |
944891147
04422381314
dr.yavana25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pen Maladu (Female Infertility), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Siddhathi Ennai (Internal) and Vediuppu Chunnam (Internal) |
Siddhathi Ennai is a herbal formulation, 10ml, OD dose at morning oral route 3 days duration.
Vediuppu Chunnam is a herbo mineral formulation, 500mg, BID dose oral route 96 days duration |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female who doesn’t have chance of conception
for 1 year after Marriage with frequent
unprotected sexual intercourse.
2. Patient willing to undergo USG, Follicular study, Hormonal assay &Routine blood investigation.
|
|
| ExclusionCriteria |
| Details |
1. Endometriosis
2. Uterine Malformation
3. Any Major systemic illness [diabetes, hypertension, heart failure, renal failure..]
4. Genito urinary tuberculosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enabling the patient to conceive |
PRE STUDY SCREENING AND AFTER
TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Attain normal regular menstrual cycle
2.Restoration of Follicular maturation
3. Changes of PCOD in USG findings
4. Correction of hormonal imbalance
|
Before treatment and After treatment |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
17/03/2017 |
| 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
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a single, non randomized, open label trial to determine the efficacy and safety of Siddhathi Ennai (Prepared from herbal constitutents) and Vediuppu Chunnam (Prepared from herbo mineral constitutents) in patients with Pen maladu (Female infertility). In this trial 10 patients will be recruited and the trial drug will be administered. Siddhathi Ennai 10ml OD dose at morning oral route 3 days duration and Vediuppu Chunnam 500mg BID dose oral route 96 days duration. During this trail period all the study related data will be recorded and documented in a page separate trial master file for each patients. During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance department in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The out come of this trial will be published in Indian Journal of Medical Research. |