Clinical Trial Details (PDF Generation Date :- Fri, 12 Apr 2019 07:28:50 GMT) CTRI Number Last Modified On 18/05/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2016/05/006954 [Registered on: 20/05/2016] - Trial Registered Retrospectively No Interventional Ayurveda Single Arm Trial Clinical Study to Evaluate the Efficacy and Safety of Ayurvedic Medicine Rasnalasoona for Cervical Spondylosis in Adults. An Open Label, Prospective, Multicentric, Non-Comparative, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Ayurvedic Proprietary Medicine- Rasnalasoona in the Management of Cervical Spondylosis in Adult Subjects Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) AHC/ORT/026/14 Ver 01 Dated 24-Jun-14 Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Source of Monetary or Material Support > Dhathri Ayurveda Private Limited 33/1886, Adappilly Road, Vennala P.O., Ernakulam- 682 028. Kerala Type of Sponsor Primary Sponsor Details Dhathri Ayurveda Private Limited 33/1886, Adappilly Road, Vennala P.O., Ernakulam- 682 028. Kerala Pharmaceutical industry-n Research and Development Private Limited List of Countries of Principal Investigator Dr K Chandrasekar DOrtho DipNB Ortho MNAMS Dr SV Sathyanarayanan MBBS DORTH MSORTH FICS 180/109, G1-G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, - 600 024. of Site Site Phone// KHM Hospital S.V. Bone and Joint Hospital No. AB-14, 6th Main Road, Anna Nagar, - 600 040. No. 177, Rangarajapuram Road, Kodambakkam, - 600 024. 9884049046 kcskotc@gmail.com 9841024926 svbjh@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Universal Ethics Committee ( based Independent Ethics Committee) Universal Ethics Committee ( based Independent Ethics Committee) Status Health Type Patients Approved 15/09/2014 Yes Approved 15/09/2014 Yes Date No Date Specified Condition Cervical Spondylosis Type Details Intervention Rasnalasoona tablet The Investigational Product is an Ayurvedic Proprietary Medicine used in the Management of Cervical Spondylosis. Dosage: Oral, 2 tablets BID (twice daily) for 8 weeks. Comparator Agent Not applicable (Single Arm page 2 / 5
Inclusion Criteria Age From Age To Gender Details 21.00 Year(s) 45.00 Year(s) Both Inclusion Criteria 1. Male and female subjects between the ages of 21 and 45 years (both ages inclusive). 2. Subjects with clinically and radiologically confirmed diagnosis of cervical stenosis, cervical spondylosis or cervical radiculopathy within the last 6 months. 3. Neck Disability Index: Screening Score of 20-35. 4. Visual Analogue Scale: Screening Score of?5. 5. Subjects who have had one or more episodes of neck pain, neck stiffness attack on average per month for at least 3 months. 6. Subjects displaying a minimum of three of the following symptoms as evaluated by the physician. i. Cervical pain aggravated by movement ii. Pain in occiput, shoulder blades or upper limbs. iii. Retro-orbital or temporal pain. iv. Cervical stiffness. v. Localised tenderness, pain or numbness of upper limbs. vi. Dizziness or vertigo attributed to cervical pain. Exclusion Criteria Details Exclusion Criteria 1. Subjects with known or suspected allergies/hypersensitivities to herbal or Ayurvedic medicines. 2. Subjects who are clinically diagnosed with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis. 3. Subjects with known history or diagnosis of advanced cervical radiculopathy, bony spurs, cervical myelopathy, cervical malignancies, lesions. 4. Subjects with known history of cervical/spinal surgery, trauma, fracture, tumors, infections, instability, deformity or whiplash within the last 2 years. 5. Subjects with history of major neurological disorder such a stroke, myasthenia gravis, muscular dystrophy, myotonic dystrophy, sclerosis. 6. Subjects with cardiac, hepatic and renal dysfunction. 7. Subjects with diagnosis of diabetes mellitus or hypertension. 8. Subjects with traumatic soft tissue injuries to the cervical region in the last 1 year. 9. Subjects who are known to be asthmatic or immunocomprised. 10. Subjects who are on regular DMARD, NSAID or other treatments for cervical pain for 1 month before screening. 11. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 12. Subjects who are known/reported to be pregnant, lactating, planning a pregnancy or unwilling to practice double barrier contraceptive method. 13. Subjects who in the opinion of the investigator is deemed unfit to participate in the study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Open Label page 3 / 5
Primary Outcome Outcome Timepoints 1. Neck Disability Index: Reduction in screening scores by?50% at end of study. 2. Visual Analogue Scale: Improvement by?4 scores at end of study. 3. Radiology Assessments: Physician s Impression of Change Scale: Score of 2 or 1 at end of study. 4. Quality of life Questionnaire: Improvement by?10 scores at end of study. 1. Neck Disability Index: Visit 0 (Screening Assessment), Visit 2,3 and 4 (6 weeks) 2. Visual Analogue Scale: Visit 0 (Screening Assessment), Visit 2,3and4 (6 weeks) 3. Radiological Assessments: Visit 4 (End of 4. Quality of life Questionnaire: Visit 1(Enrollment), Visit 2,3, and 4 (6 weeks) Secondary Outcome Outcome Timepoints 1. Neck Disability Index: Reduction in screening scores by 49-25% at end of study. 2. Visual Analogue Scale: Improvement by 2 scores at end of study. 3. Radiology Assessments: Physician s Impression of Change Scale: Score of 3 at end of study. 4. Quality of life Questionnaire: Improvement by 5-9 scores at end of study. 1. Neck Disability Index: Visit 0 (Screening Assessment), Visit 2,3 and 4 (6 weeks) 2. Visual Analogue Scale: Visit 0 (Screening Assessment), Visit 2,3and4 (6 weeks) 3. Radiological Assessments: Visit 4 (End of 4. Quality of life Questionnaire: Visit 1(Enrollment), Visit 2,3, and 4 (6 weeks) Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=40 Sample Size from =40 N/A 15/12/2014 No Date Specified Years=0 Months=2 Days=7 Suspended Not yet Study Design An Open Label, Prospective, Multicentric, Non Comparative, Single Arm The study is planned to evaluate the data from 40 evaluable subjects as per regulatory norms for a clinical study on an Ayurvedic proprietary medicine. The study is spread over 9 weeks with one week of runin period between screening and enrollment and 8 weeks of treatment with the investigational product. The consumption of the tablet is restricted to 2 tablets BID (twice daily) after food for 8 weeks. The study assessments include radiological assessments CT scan and X ray of head and neck, physician s clinical assessment and subjective assessments. The assessments inclusive of subjective questionnaire assessments are all designed as per the allopathic system of medicine to standardize the evaluation criteria and add reliability to the results of this study. A self analysis of Prakrithi of the subject is performed at the start of the study to allow the subanalysis of the effectiveness of the investigational product and its possible varied reflection on page 4 / 5
Powered by TCPDF (www.tcpdf.org) different constituents doshas as per the Ayurvedic system of medicine. Safety investigations such as complete blood count and serum biochemistry are also performed, to evaluate general health status. Rasnalasoona tablet consists of extracts from Alpinia galangal, Allium sativum, Shankabasmam and other extracts page 5 / 5