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CTRI Number  CTRI/2019/11/022186 [Registered on: 27/11/2019] Trial Registered Prospectively
Last Modified On: 22/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Homeopathic formulation in patient with Cervical spondylosis 
Scientific Title of Study   An open Label, non-randomised, clinical study to evaluate the efficacy and safety of homeopathic formulation of Spondin drops in patient with Cervical spondylosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MCR/BHAR/SD/CT/007/9102 Version: Original Protocol  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjali Sable 
Designation  Head of Clinical Operation 
Affiliation  Milagro Clinical Research 
Address  Office No A 615, Balaji Bhavan Sector 11, CBD Belapur, Navi Mumbai.

Thane
MAHARASHTRA
400614
India 
Phone  917400407196  
Fax  02227562224  
Email  anjali@milagroclinicalresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Trupti Desai 
Designation  Regulatory and Start Up Lead 
Affiliation  Milagro Clinical Research 
Address  Office No A 615, Balaji Bhavan Sector 11, CBD Belapur, Navi Mumbai.

Thane
MAHARASHTRA
400614
India 
Phone  917400407193  
Fax  02227562224  
Email  trupti@milagroclinicalresearch.com  
 
Details of Contact Person
Public Query  
Name  Rajeshwari Sorte 
Designation  Medical Documents Specialist 
Affiliation  Milagro Clinical Research 
Address  Office No A 615, Balaji Bhavan Sector 11, CBD Belapur, Navi Mumbai.

Thane
MAHARASHTRA
400614
India 
Phone  917400407197  
Fax  02227562224  
Email  rajeshwari.milagro@gmail.com  
 
Source of Monetary or Material Support  
Bhargava Phytolab Limited E 1216 Ghatal Bhiwadi industrial area, Bhawadi, Rajastan India 301019  
 
Primary Sponsor  
Name  Bhargava Phytolab Limited 
Address  E 1216, Ghatal, Bhiwadi Industrial Area, Bhiwadi, Rajastan, India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Milagro Clinical Research  Milagro Clinical Research Office no A-615, Balaji Bhavan, Sector-11, CBD Belapur- 400614.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Girish Kulkarni  Dr Kulkarni Clinic  Sector 8, Plot No 10, Phase Ii, Trupti Shopping Centre, Nerul (W), Jai Bhavani Marg, Navi Mumbai, Maharashtra. 400706.
Thane
MAHARASHTRA 		 917400407195
02227562224
girishkulkarni645@gmail.com 
Dr Bhushan Badgujar  SANJIVANI CLINIC  Shop No. 1, Neera Niwas,Gaon Devi Road, Sec. 36, Karave Gaon, Nerul (W.), Navi Mumbai – 400 706. Maharashtra, India.
Thane
MAHARASHTRA 		 917400407195
02227562224
bhushanbadagujar212@gmail.com 
Dr Dilip Mundhe  Siddhivinayak Clinic  Siddhivinayak Clinic, F5/02, Sector-7, Simplex, Ghansoli, Navi Mumbai.
Thane
MAHARASHTRA 		 917400407195
02227562224
dilipmundhe.m@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Vision Independent Ethics Committee  Approved 
Vision Independent Ethics Committee  Approved 
Vision Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Spondin Drops  All eligible subjects who meet the Inclusion and Exclusion Criteria will be enrolled into the study will have to visit the study site on screening, Day 0 (Baseline visit), Day 20, Day 40 and Day 60. 100 subjects will be enrolled. Subjects in study will receive active Investigational Product and advised to take 15 Drops in half cup of lukewarm water thrice a day after food Physical examination and Demographics will be recorded at the screening time Physical examination and monitoring will be continuing Day 20, Day 40 and Day 60. Vitals will be recorded on all the visits. X-Ray for (Cervical region) at the baseline and final visit Visual Analog Scale (VAS) Score on all visits (Intensity of pain will be graded from 0-9. Pain, Intensity and X-ray changes will be assessed in each case) Adverse events will be monitored up to 60 days and will be recorded on Day 20, Day 40 and Day 60. A buffer period of ±3 days will be allowed for every visit and beyond which it will be considered as a protocol deviation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The Inclusion criteria are as follows (“Yes” to all the following will allow the subjects to be included into study)
1. Age: Adult-Above 18 years to Below 60 years, both male and female
2. Willing to sign written inform consent
3. Patients recently diagnosed with Cervical spondylosis, the following signs and symptoms
Pain in neck and Referred pain (occiput, between the shoulder blades, upper limbs) Pain in Back and Shoulder
Tenderness
Difficulty in neck movements
Dizziness or vertigo
4. Confirmation of Cervical Spondylosis by
X-ray- Cervical region

 
 
ExclusionCriteria 
Details  The exclusion criteria are as follows (“Yes” to any one of the following will allow PI to exclude the subject from enrolling into the study
1. Severe neurological conditions like severe neuropathy
2. Inflammatory diseases like Osteoarthritis, Rheumatoid Arthritis and Ankylosing spondylitis
3. Evidence of a specific pathologic condition herniated disc and any malignancy.
4. Past h/o Fracture
5. Past h/o Neck surgery
6. Inability to sign inform consent
7. Patients with k/h/o DM and HTN
8. H/o renal, hepatic or hematopoietic disorder or severe cardiac insufficiency
9. K/h/o hypersensitivity to herbal extracts or dietary supplements
10. Pregnant women, lactating women and women of childbearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Signs and symptoms of Cervical Spondylosis
Safety is assessed through the number of adverse events, the number and nature of abnormal laboratory results.
 		 60 days
 
 
Secondary Outcome  
Outcome  TimePoints 
Symptomatic relief from clinical symptoms of Cervical Spondylosis
Mean Change in Visual Analog Scale (VAS) Chart score from baseline to end of treatment.
 		 60 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   28/11/2019 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

All eligible subjects who meet the Inclusion and Exclusion Criteria will be enrolled into the study will have to visit the study site on screening, Day 0 (Baseline visit), Day 20, Day 40 and Day 60.

100 subjects will be enrolled.

Subjects in study will receive active Investigational Product and advised to take 15 Drops in half cup of lukewarm water thrice a day after food Physical examination and Demographics will be recorded at the screening time.

Physical examination and monitoring will be continuing Day 20, Day 40 and Day 60.

Vitals will be recorded on all the visits.

X-Ray for (Cervical region) at the baseline and final visit

Visual Analog Scale (VAS) Score on all visits

(Intensity of pain will be graded from 0-9. Pain, Intensity and X-ray changes will be assessed in each case)

Adverse events will be monitored up to 60 days and will be recorded on Day 20, Day 40 and Day 60. A buffer period of ±3 days will be allowed for every visit and beyond which it will be considered as a protocol deviation.

 
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