| CTRI Number |
CTRI/2022/02/040297 [Registered on: 15/02/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preclinical and clinical evaluation of the effect of Siddha classical drug PARUMA NOI NIVARANA MAATHIRAI & NEERMULLI OORAL KUDINEER (oral administration ) along with PODI THIMIRTHAL ( external therapy) in the management of CHILDHOOD OBESITY. |
|
Scientific Title of Study
|
Preclinical and clinical evaluation of the effect on oral administration of PARUMA NOI NIVARANA MAATHIRAI & NEERMULLI OORAL KUDINEER along with external therapy PODI THIMIRTHAL in the management of BAALAR ATHITHOOLA ROGAM. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J MANGALAVALLI |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
II year PG Scholar,
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
II year PG Scholar,
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
6238264836 |
| Fax |
|
| Email |
sreejashenoi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D K SOUNDARARAJAN MDs |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D K SOUNDARARAJAN MDs |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital,
Palayamakottai,
Tirunelveli
627002
|
|
|
Primary Sponsor
|
| Name |
Dr J Mangalavalli |
| Address |
II year,PG Scholar,
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamakottai,
Tirunelveli
627002
|
| Type of Sponsor |
Other [self] |
|
|
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 J Mangalavalli |
Government Siddha Medical College and Hospital, ,Palayamkottai,Tirunelveli,627002 |
Department of Kuzhanthai Maruthuvam,Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli,627002
Tirunelveli
TAMIL NADU |
6238264836
sreejashenoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, (2) ICD-10 Condition: E65||Localized adiposity, (3) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NEERMULLI OORAL KUDINEER (0ral administration) |
DOSE : 15 -30 ml |
| Comparator Agent |
Nil |
Nil |
| Intervention |
PARUMA NOI NIVARANA MAATHIRAI (0ral adminstration)
|
PARUMA NOI NIVARANA MAATHIRAI
DOSE : 1 pill BD BF for 40 days(According to the age of the patient)
ADJUVANT : Water
|
| Intervention |
PODI THIMIRTHAL (External therapy) |
Massage with dry herbal powders
Rubbing with herbal powders all over the body.To be done in upward direction only.
DURATION : usually 30 -45 minutes x 5 sittings weekly. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Inappropriate weight for height
2.Raised BMI
3.Abdominal adiposity
4.Increased skin fold thickness
All of these associated with any one of the following :
a.Shortness of breath
b.Dark and thickened skin especially in the skin folds and creases
c.Joint pain
d.Trouble sleeping
5.Willing for regular follow-up in OPD
6.Willing to put admission in IPD |
|
| ExclusionCriteria |
| Details |
1.Children above 12 years
2.Children below 5 years
3.Cases due to endocrine reasons
4.Hypothalamic obesity
5.Genectic syndromes
6.Monogenic disorders
7.Under the use of antiepileptic drugs,corticosteroids,antipsychotics,antidepressants and oestrogen
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To reduce the excess weight
2.To maintain weight within normal limits. |
40 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/02/2022 |
| Date of Study Completion (India) |
17/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1.THE DISPARATE APPROACHES FOR IDENTIFYING THE POTENTIAL OF PARUMA NOI NIVARANA MAATHIRAI IN THE MANAGEMENT OF BALAR ATHITHOOLA ROGAM.
2.BIOCHEMICAL SCREENING ANALYSIS OF MEDAATHI CHOORNAM FOR THE MANAGEMENT OF BALAR KEEL VAYU |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is a single arm clinical trial focussing on preclinical and clinical evaluation of the effect on oral adminiostration of PARUMA NOI NIVARANA MAATHIRAI & NEERMULLI OORAL KUDINEER along with external therapy PODI THIMIRTHAL in the management of BAALAR ATHITHOOLA ROGAM.
If any ADR is encountered , it will be reported to Pharmacovigilance department , SCRU Palayamkottai. |