| CTRI Number |
CTRI/2025/12/098882 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Kokilakshadi Capsules in Managing Pain and Swelling: A Clinical Study |
|
Scientific Title of Study
|
Evaluation of the Analgesic and Anti Inflammatory Effect of Kokilakshadi Capsule : A Quasi Experimental study |
| 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 Anoop AK |
| Designation |
Medical officer |
| Affiliation |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal |
| Address |
Department of Clinical Research and marketing
Vaidyaratnam P S Variers Aryavaidysala Kottakkal Malappuram
Malappuram
KERALA
676503
India |
| Phone |
04832806520 |
| Fax |
|
| Email |
researchmarketing@aryavaidyasala.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anoop AK |
| Designation |
Medical officer |
| Affiliation |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal |
| Address |
Department of Clinical Research and marketing
Vaidyaratnam P S Variers Aryavaidysala Kottakkal Malappuram
Malappuram
KERALA
676503
India |
| Phone |
04832806520 |
| Fax |
|
| Email |
researchmarketing@aryavaidyasala.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anoop AK |
| Designation |
Medical officer |
| Affiliation |
Vaidyaratnam P S Variers Aryavaidyasala Kottakkal |
| Address |
Department of Clinical Research and marketing
Vaidyaratnam P S Variers Aryavaidysala Kottakkal Malappuram
Malappuram
KERALA
676503
India |
| Phone |
04832806520 |
| Fax |
|
| Email |
researchmarketing@aryavaidyasala.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam P.S Varier Aryavaidyasala Kottakkal P.O Malappuram Kerala 676503 |
|
|
Primary Sponsor
|
| Name |
The managing trustee |
| Address |
Vaidyaratnam P S Varier Aryavaidyasala Kottakkal Malappuram 676503 |
| Type of Sponsor |
Other [Charitable institution] |
|
|
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 Anoop AK |
Arya Vaidya Sala, Kottakkal |
Special OPD
Malappuram
KERALA |
04832806520
researchmarketing@aryavaidyasala.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Aryavaidyasala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M95-M95||Other disorders of the musculoskeletal system and connective tissue. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Kokilakshadi capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 2(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
At least one episode of swelling, pain or tenderness in a peripheral joint or bursa |
|
| ExclusionCriteria |
| Details |
Known case of malignancy, CVD, Endocrinal disorders, hepatic disorders, Pregnant and lactating females, and any other conditions that may jeopardize the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Noticing improvements in joint pain, swelling, and tenderness can be a significant relief
|
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved blood parameters: reduced ESR, CRP, RA Factor, and Serum Uric Acid |
21 days |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3 |
|
Date of First Enrollment (India)
|
09/01/2026 |
| 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="0"
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
|
The drug with both anti-inflammatory and
analgesic effects is highly relevant today , not just for symptom control,
but also for Modifying disease progression, Improving quality of life
and for Reducing the societal and economic burden of chronic pain and
inflammation. The study entitled Evaluation of the Analgesic and Anti inflammatory effect of Kokilakshadi capsule a Quasi Experimental study aims to assess the safety and effectiveness of Kokilakshadi Capsule as a natural analgesic and anti-inflammatory agent in multiple pain-related conditions, using standardized clinical and laboratory outcome measures |