| CTRI Number |
CTRI/2024/06/069031 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trail on parangisakkai chooranam in the management of soothagavaayu(PCOD) |
|
Scientific Title of Study
|
A prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to evaluate the efficacy of Parangisakkai chooranam in the management of soothagavaayu(PCOD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Priyadharshini |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Op no:10,
PG Department of Pothu Maruthuvam,
Government siddha medical College and hospital,
Thiruvananthapuram main road, Palayamkottai,
Tirunelveli-627002.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8754757767 |
| Fax |
|
| Email |
harshiriya11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr T Komalavalli |
| Designation |
Head of the department |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Op no:10,
PG department of Pothu Maruthuvam,
Government siddha medical College and hospital,
Palayamkottai,
Tirunelveli-627002.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248497477 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T Komalavalli |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Op no:10,
PG department of Pothu Maruthuvam,
Government siddha medical college and hospital,
Palayamkottai,
Tirunelveli-627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248497477 |
| Fax |
|
| Email |
Komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital,
Palayamkottai,
Tirunelveli - 627002,
Tamilnadu,
India. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital,Thiruvananthapuram main road, Palayamkottai,Tirunelveli-627002, Tamilnadu, India |
| 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 R PRIYA DHARSHINI |
Government Siddha Medical College and Hospital |
Op number 10,
PG Department of Pothu maruthuvam,
Government siddha medical college and hospital,
Thiruvananthapuram main road,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU |
8754757767
harshiriya11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical College and Hospital Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PARANGISAKKAI CHOORANAM |
3-6 grams twice a day orally with hot water for 3 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Menstrual irregularities
(Secondary amenorrhea)
(Oligo amenorrhea)
2.Hyperandrogenism(clinical/Biochemical)
3.polycystic ovaries (unilateral/bilateral)
4.seeking treatment for PCOS induced infertility
|
|
| ExclusionCriteria |
| Details |
1.Diabetes mellitus
2.Hypertension
3.pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is mainly assessed for minimum 3 menstrual cycles by
1.Regulation of menstrual cycle
2.Regulation of hormonal profile
3.Disappearance/reduction in the size or number of cyst.
Regulation of hormonal profile |
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate physicochemical, phytochemicals, biochemical analysis of clinical trial drug
To evaluate the safety profile for acute and subacute toxicity of the trial drug
To evaluate Antioxidant, Antidiabetic activity of the trial drug
To evaluate the pharmacological analysis of the clinical trial drug
To evaluate various siddha parameters. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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 Yet Recruiting |
| 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
|
This study is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRAIL TO DETERMINE THE EFFECTIVENESS OF PARANGISAKKAI CHOORANAM IN THE MANAGEMENT OF SOOTHAGAVAAYU (PCOD). The primary outcome will be regulation of menstrual cycle, regulation of hormonal profile and regulation of ovulation. The secondary outcome will be evaluating the diagnostic parameters, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) noticed, it will be referred to pharmacovigilance department Of SCRI. Further management of patients will be given in OPD facility. |