| CTRI Number |
CTRI/2025/07/091299 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Safety and Efficacy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Check the Safety and Effectiveness of Dharasana Lep in People with Mild to Moderate Muscle, Joint, or Rheumatic Pain |
|
Scientific Title of Study
|
A Prospective, Open-Label, Single-Centre Interventional Study to Evaluate the Efficacy and Safety of Dharasana Lep in Patients with Mild to Moderate Musculoskeletal Pain and Rheumatoid Arthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250029-SM_1.0_07Jul25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harsh Raval |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Clinical trial Department office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub-Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Clinical trial Department office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari N Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Clinical trial Department office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Shah Maganlal Chunilal Gandhi |
|
|
Primary Sponsor
|
| Name |
Shah Maganlal Chunilal Gandhi |
| Address |
Vraj Thakor Near Mota Bazar,
Valsad, Gujarat, India-396001 |
| Type of Sponsor |
Other [Manufacturer of Ayurvedic 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 Nayan Patel |
NovoBliss Research Pvt. Limited |
Clinical Trial Department,
NovoBliss Research Pvt. Ltd.
Office# 313, Silver Radiance-4, Gota,
Ahmedabad- 382481, Gujarat, India
Ahmadabad
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M255||Pain in joint. Ayurveda Condition: DOSHAVASTHA (VATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Participants will be advised to follow a regular daily routine including timely meals, adequate sleep, and light physical activity. They will be instructed to avoid stress, alcohol, tobacco, and disturbing the Lep application site., Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 25-65 years (both inclusive) at the time of consent.
2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3) Subject is in good general health as determined by the Investigator on the basis of medical history.
4) Subject must be having presence of body ache, joint or muscle pain, sprain/strain, or back pain for more than 1 week and less than 6 months.
5) Patients must have a confirmed diagnosis of mild to moderate musculoskeletal pain and rheumatic conditions with a pain score between 4 to 7, grade will be evaluated using Visual Analog Scale (VAS).
6) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
7) If the subject is of childbearing potential they must have a self-reported negative urine pregnancy, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
8) Subjects are willing to give written informed consent and are willing to follow the study procedure.
9) Subjects who commit not to use any other medicated/ prescription topical analgesics or medication, other than the test treatment for the entire duration of the study.
10) Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments.
11) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
12) Subject must be able to understand and provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1) Subject has severe arthritis requiring prescription medication including immunomodulators, COX Inhibitors, etc.
2) Subjects having any skin disorder or presence of open wounds, cut, bruising, rashes etc.
3) Subjects with raw wounds, sutures, fractures and hematoma.
4) Subjects suffering from auto-immune disorder, spastic disorder, genetic disorder and any other sever traumatic conditions.
5) Subjects with chronic pain like arthritis, gout, and ankylosing spondylitis.
6) Subject have history of any hypersensitivity to the ingredients in the Lep.
7) Subject who had taken any systemic product for any illnesses for at least 3 months.
8) History of alcohol or drug addiction.
9) Pregnant or breast feeding or planning to become pregnant during the study period.
10) History of chronic illness which may influence the cutaneous state.
11) Subject have participated any clinical research study within the last 30 days.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the effectiveness of the test treatment by assessing the change in pain intensity i.e. knee pain, swelling, back pain, muscle pain, sprains and strains from baseline before application of test treatment to post removal of test treatment. |
Day 01, Day 02 and Day 04(2 Days)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the effectiveness of the test treatment by assessing change in joint stiffness and movement from baseline before application of test treatment to post removal of test-treatment |
Day 01 and Day 04 |
| 2. To evaluate the effectiveness of the test treatment by assessing change in flexibility/extent of movement of joint from baseline before application of test treatment to post removal of test-treatment. |
Day 01 and Day 04 |
| 3. To evaluate the effectiveness of the test treatment by assessing the change in Vedana (pain) from baseline before application of test treatment to post removal of test-treatment. |
Day 01 and Day 04 |
| 4. To evaluate the effectiveness of the test treatment by accessing the change in ayurvedic clinical examination from baseline before application of test treatment to post removal of test-treatment |
Day 01 and Day 04 |
| 5. To evaluate the effectiveness of the test treatment by assessing change in product perception questionnaire, and PGIC questionnaire from baseline before application of test treatment to post removal of test treatment. |
Day 01 and Day 04 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2025 |
| Date of Study Completion (India) |
15/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="6" |
|
Recruitment Status of Trial (Global)
|
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 an open-label, single-centre, prospective, interventional, clinical study to evaluate the efficacy and safety of pain relief lep in patients with mild to moderate musculoskeletal pain and rheumatoid arthritis. A total of 35 participants will be enrolled in the study, including males and non-pregnant, non-lactating females aged between 25 and 65 years (inclusive). Participants experiencing musculoskeletal pain of mild to moderate intensity, such as knee pain, swelling, back pain, muscle sprains, or strains will be enrolled in the study. Among the total, 5 participants will have a diagnosis of Rheumatoid Arthritis with associated walking difficulty. The study aims to complete with 30 evaluable participants, accounting for potential dropouts or withdrawals during the study period.
|