| CTRI Number |
CTRI/2026/02/103710 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on the PANCHATHIKTHA GHRITAM(internal) AND VASAVU ENNAI(external) in the management of ENBU KURAL NOI (Genu valgum and Genu varum) in Paediatrics |
|
Scientific Title of Study
|
PRECLINICAL AND CLINICAL EVALUATION OF THE EFFECT ON ORAL ADMINISTRATION OF PANCHATHIKTHA GHRITAM ALONG WITH VASAVU ENNAI (THOKKANAM AND KATTU) IN THE MANAGEMENT OF ENBU KURAL NOI(GENU VALGUM AND GENU VARUM) IN PAEDIATRICS |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sripriya |
| Designation |
PG Scholar |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE,PALAYAMKOTTAI |
| Address |
PG SECOND YEAR DEPARTMENT OF KUZHANTHAI MARUTHUVAM GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI TIRUNELVELI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7358974275 |
| Fax |
|
| Email |
ahchchi9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J SRI RAM |
| Designation |
LECTURER GRADE-II |
| Affiliation |
Government Siddha medical college palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam
Government Siddha medical college palayamkottai
Lecturer
Department of Kuzhanthai Maruthuvam
Government Siddha medical college palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486811230 |
| Fax |
|
| Email |
sriramsiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J SRI RAM |
| Designation |
LECTURER GRADE-II |
| Affiliation |
Government Siddha medical college palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam
Government Siddha medical college palayamkottai
Lecturer
Department of Kuzhanthai Maruthuvam
Government Siddha medical college palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486811230 |
| Fax |
|
| Email |
sriramsiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital Palayamkottai 627002
Tirunelveli,Tamil nadu,India. |
|
|
Primary Sponsor
|
| Name |
Dr S Sripriya |
| Address |
PG Second year,department of Kuzhanthai Maruthuvam, Government siddha medical college and Hospital, Palayamkottai 627002 Tirunelveli, Tamil nadu, India |
| 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 S SRIPRIYA |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITALPALAYAMKOTTAI |
Department of Kuzhanthai Maruthuvam,Government Siddha Medical College and Hospital, Palayamkottai 627002, Tirunelveli
Tirunelveli
TAMIL NADU |
7358974275
ahchchi9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
PANCHATHIKTHA GHRITAM(ORAL ADMINISTRATION) |
SHOULD ADMINISTERED ORALLY TWICE A DAY BEFORE MEAL DOSAGE ACCORDING TO AGE AND BODY WEIGHT |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT WITH GENU VALGUM AND GENU VARUM CAUSED BY VITAMIN D DEFICIENCY
VITAMIN D DEFICIENCY INVOLVED RICKETS
CHILDREN WHO PRESENTED WITH GENU VALGUM AND GENU VARUM WITHOUT ANY CHRONIC SYSTEMIC ILLNESSES |
|
| ExclusionCriteria |
| Details |
below 2 years
above 12 years
children with Genu valgum and Genu varum without any other diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The treatment is expected to change in knee alignment and limb angle measurement(degree of Genu valgum and Genu varum),improve the quality of life in children without the need for surgery. It will provide scientific validation for the Siddha formulations Panchathiktha ghritam and Vasavu ennai in pediatric care |
The Study outcomes,including reduce the curvature of lower limbs at the knee joint and improve the quality of life,will be assessed at predefined time points-at baseline (day 0),at the end of the treatment (day 48),and follow-up (Day 90)-to evaluate both the immediate and sustained effects of the Siddha formulations Panchathiktha ghritam and Vasavu Ennai without the need for surgical intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Nutritional deficiency is involved in growth and development of paediatrics. Vitamin d deficiency is influence in bone and muscles’ health and development. this deficiency is main reason for Genu valgum and Genu varum those are common knee deformities in children. Genu valgum is knock knee is characterised by the curving inward are and touching each other while ankles apart when standing. Genu varum is called bow leg is the opposite with the knee curving outward and the ankle touching while the knees are apart.the higher prevalence of vitamin D deficiency is significant indicate in sun rich country like India several reasons including inadequate expose to sunlight, dietary factors such as inadequate vitamin D and calcium intake,intake of caffeine,high prevalence of lactose intolerance.In Siddha text like thirumanthiram mentioned the word kural to describe as deformity.Panchathiktha Ghritam is type of medicine has main ingredient is Ghee it is good content of Vitamin D and Calcium.Vasavu ennai is to release the stiffness of muscle.
Objective To evaluate the combine effect of Panchathktha Ghritam(Internal) and Vasavu ennai (External) (Thokkanam and Kattu) in the management of Enbu Kural Noi (Genu valgum and Genu varum) |