| CTRI Number |
CTRI/2026/03/106033 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Varma thadaval] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Varma massage with Varma oil and Piratharani kasayam in patients with Adhesive Capsulitis (Frozen Shoulder) |
|
Scientific Title of Study
|
An open labelled double arm non randomized phase II clinical trial,“To Compare the effectiveness of Varma Thadaval Murai(Kai Varma Ennai-II-External oil) with Piratharani Kasayam(Internal) in the Management of Kumbavatham(Adhesive Capsulitis)” |
| 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 A MOHIDEEN FATHIMA |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
OP no 14,PG Department of Varma Maruthuvam, Government Siddha Medical college and hospital,Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9790387872 |
| Fax |
|
| Email |
ayupfathi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R VANAMAMALAI MDS |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op No 14,PG Department of Varma Maruthuvam, Government Siddha Medical college and hospital,Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9965606156 |
| Fax |
|
| Email |
drvanamamalai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R KRISHNAMOORTHI MDS |
| Designation |
Associate Professor and Head of the Department of Varma Maruthuvam |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op No 14,PG Department of Varma Maruthuvam, Government Siddha Medical college and hospital,Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442545017 |
| Fax |
|
| Email |
arksiddh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Governemnt Siddha Medical College and Hospital ,Palayamkottai ,Tirunelveli - 627002 ,
Tamilnadu , India |
|
|
Primary Sponsor
|
| Name |
Governemnt Siddha Medical College |
| Address |
Government Siddha Medical College and Hopital,Palayamkottai,Tirunelveli - 627002 |
| 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 A MOHIDEEN FATHIMA |
Government Siddha Medical college and hospital |
OP no 14,PG Department of Varma Maruthuvam, Government Siddha Medical college and hospital,Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU |
9790387872
ayupfathi1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Siddha Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Piratharani Kasayam (Internal) |
Piratharani Kasayam will be administered orally at a dose of 90 ml twice daily(BD) for 21 days. |
| Intervention |
Varma Thadaval Murai (Kai Varma Ennai-II-External Oil) |
Varma Thadaval will be performed using Kai Varma Ennai-II-External Oil.The oil is applied externally over the affected shoulder once daily for 21 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Presence of Pain, stiffness and restricted movements in the shoulder joint.
2.Idiopathic cases of adhesive capsulitis.
3.Patients assessed using the SPADI score.
4.History of Diabetes Mellitus.
5.Patients willing to participate and sign the informed consent form.
6.Patients willing to undergo treatment and attend regular follow-up. |
|
| ExclusionCriteria |
| Details |
1.History of fracture or surgery of the affected shoulder joint.
2.Autoimmune or inflammatory joint disorders affecting the shoulder.
3.Cardiovascular disease.
4.Tuberculosis or other active systemic infections.
5.Congenital deformities of the shoulder.
6.Pregnant and lactating women.
7.Skin diseases or infection over the affected shoulder region. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in SPADI(Shoulder Pain and Disability Index) score and shoulder joint range of motion measured by goniometer |
Baseline and Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of safety and adverse events during the treatment period. |
Baseline and Day 21 |
|
|
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)
|
26/03/2026 |
| 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 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
|
Adhesive Capsulitis (Frozen shoulder) is a disabling condition characterized by pain, stiffness, and restriction of shoulder movements, resulting in limitation of daily activities. In Varma literature, this condition is correlated with Kumbavatham and is managed using external and internal therapeutic approaches. The present study is open-labelled, double-arm, non-randomized phase II clinical effectiveness of Varma Thadaval Murai performed with Kai Varma Ennai-II and the internal administration of Piratharani Kasayam in a dose of 90 ml in patients with adhesive capsulitis. Eligible participants will be allocated into two treatment groups and treated for a period of 21 days. Clinical outcomes will be assessed by Shoulder Pain and Disability Index (SPADI) score and shoulder joint range of motion measured using a goniometer at baseline and Day 21. Safety and tolerability of the interventions will also be assessed during the study. |