| CTRI Number |
CTRI/2025/11/097528 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical Herbal Cream] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the effectiveness and safety of NKAFE cream for muscle and joint comfort. |
|
Scientific Title of Study
|
A prospective, randomized, double-blind, single-center, placebo-controlled, 2 arm clinical study to assess efficacy, safety and tolerability of topically administered NKAFE cream in supporting muscle and joint comfort. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EHC-TPR-CT01-25 version 1.0 dated 29 September 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidyadhar Kumbhar |
| Designation |
Principal Investigator |
| Affiliation |
Sunad Ayurved |
| Address |
Siddhivinayak Apartment shop no. 2, 3, 4, Jeevan Nagar, Dhoka Colony, Chinchwad, Pimpri-Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
919960075536 |
| Fax |
|
| Email |
dr.vidyadhar24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sornaraja Thasma |
| Designation |
Director, Quality and Business |
| Affiliation |
ProRelix Services LLP |
| Address |
ProRelix Services LLP 102 A/B Park Plaza Main Karve Nagar Chowk Karve Nagar Pune Maharashtra
Pune
MAHARASHTRA
411052
India |
| Phone |
918124806366 |
| Fax |
|
| Email |
s.thasma@prorelixresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Aditi Vaidya |
| Designation |
Senior Manager, CR Operations |
| Affiliation |
ProRelix Services LLP |
| Address |
ProRelix Services LLP 102 A/B Park Plaza Main Karve Nagar Chowk Karve Nagar Pune Maharashtra
Pune
MAHARASHTRA
411052
India |
| Phone |
918602571013 |
| Fax |
|
| Email |
a.vaidya@prorelixresearch.com |
|
|
Source of Monetary or Material Support
|
| Endeavour Consumer Health
14-18 Lovell Court, Rosedale, Auckland 0632, New Zealand |
|
|
Primary Sponsor
|
| Name |
Endeavour Consumer Health |
| Address |
14-18 Lovell Court, Rosedale, Auckland 0632, New Zealand |
| Type of Sponsor |
Other [marketer and wholesaler of health products] |
|
|
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 Vidyadhar Kumbhar |
Sunad Ayurved |
Siddhivinayak Apartment shop no. 2, 3, 4, Jeevan Nagar, Dhoka Colony, Chinchwad, Pimpri-Chinchwad, 411033
Pune
MAHARASHTRA |
09960075536
dr.vidyadhar24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
local musculoskeletal pain or discomfort |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NKAFE cream |
herbal cream to be applied liberally at least twice a day on affected area for 7 days. |
| Comparator Agent |
Placebo cream |
placebo cream to be applied liberally at least twice a day on affected area for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males or females aged of 19-65 years (both inclusive).
2. Participant with acute or chronic localized musculoskeletal pain or musculoskeletal discomfort.
3. Participant willing to give written informed consent.
4. Participant willing to come for visits at the site as per protocol.
5. Participant willing to use the investigational product as instructed per protocol.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant, lactating women. 2. Use of any topical agents on the affected area within 3 days of screening or enrolment. 3. Subject with active skin lesions or skin disease or with cutaneous manifestations of systemic illnesses. 4. Subject with active cancer, spinal cord lesions or spine surgery. 5. Subject with history of alcohol or drug abuse within 1 year. 6. Subject with history of severe cardiac, liver or kidney disease or any other medical condition that may interfere with the ability of the subject to participate in the study as determined by the Investigator. 7. Patients already on oral NSAIDs or analgesics.
8. Contraindication or allergy to any substance in the investigational product. 9. Currently, or within the past 30 days, enrolled in a different clinical investigation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of change in pain score at rest (Visual Analog Scale), change in pain score in motion (Visual Analog Scale), muscle stiffness measured by Numerical Rating Scale (NRS), severity of pain on a 5-point rating scale of very severe, severe, moderate, mild and none, evaluation of severity of stiffness on a 5-point rating scale of very severe, severe, moderate, and mild and none. |
Baseline (Day 1) and End of study (Day 7) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tolerability based on a four-point scale (0–3) for erythema, scaling, dryness, pruritus, and burning/stinging. |
End of study (Day 7) |
| Patient Global Assessment of Treatment Tolerability (PGATT) (overall tolerability) |
End of study (Day 7) |
| Treatment Emergent Adverse Event |
Randomization visit to End of Study |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
14/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a prospective, randomized,
double-blind, single-center, placebo-controlled, 2 arm parallel clinical study.
Male and female participants with acute
or chronic localized musculoskeletal pain or musculoskeletal discomfort will be
enrolled in the study. A total of 22 subjects, including approx. 10% dropout
will be screened and randomly assigned in 1:1 ratio to NKAFE cream or Placebo
cream group i.e. 11 participants in each group. |