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CTRI Number  CTRI/2021/11/037879 [Registered on: 08/11/2021] Trial Registered Prospectively
Last Modified On: 26/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Using Homeopathic Combinations for Treatment of Pain 
Scientific Title of Study   Evaluating the Efficacy of Homeopathic Combinations for the Treatment of Musculoskeletal Pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Agarwal 
Designation  Professor and Head 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences 
Address  Department of Anesthesiology
Rae Bareilly Road Lucknow 226 014
Lucknow
UTTAR PRADESH
226 014
India 
Phone  9670371790  
Fax    
Email  anil_sgpgi@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RK JAISWAL 
Designation  Assistant Professor 
Affiliation  National Homoeopathic Medical College & Hospital 
Address  Department of Physiology and Biochemistry
Hanyman Chauraha Lucknow
Lucknow
UTTAR PRADESH
226028
India 
Phone  9415620515  
Fax    
Email  dr.rajhomeocure@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Piyush Gupta 
Designation  Secretary and PEO 
Affiliation  Cancer Aid Society 
Address  Head Office
401 Sunshine Court 2 66C Prag Narain Road
Lucknow
UTTAR PRADESH
226001
India 
Phone  09335166600  
Fax    
Email  piyushgupta@canceraidsocietyindia.org  
 
Source of Monetary or Material Support  
Cancer Aid Society 
 
Primary Sponsor  
Name  Cancer Aid Society 
Address  4th Floor Sunshine Court 2 66C Prag Narain Road, Lucknow, UP 
Type of Sponsor  Other [Society] 
 
Details of Secondary Sponsor  
Name  Address 
National Association of Palliative Care for AYUSH Integrative Medicine  4th Floor, Sunshine Court 2, 66C Prag Narain Road, Lucknow, UP 226001  
Zuhause Heilen Pvt Ltd  21/N, 7 Tilak Marg, Dalibagh, Lucknow, UP 226001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Piyush Gupta  Cancer Aid Society Head Office  4th Floor Sunshine Court 2, 66C Prag Narain Road Hazratganj
Lucknow
UTTAR PRADESH 
9335166600

piyushgupta@canceraidsocietyindia.org 
Dr Anil Agarwal  SGPGIMS  Dept. of Anesthesia SGPGIMS, Raebareilly Road Lucknow, UP
Lucknow
UTTAR PRADESH 
9670371790

anil_sgpgi@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Cancer Aid Society Ethics Committee  Approved 
Cancer Aid Society Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Pain relief using homeopathic combination  3 Pills to be taken every 10 minutes 3 times in morning followed by 3 pills every 6 hourly for 1 week and then after 1 month. The efficacy of the combination will be assessed with Visual analogue Scale (VAS) and RAND Short form-36 health related quality of life questionnaire (SF-36). The VAS score will be assessed from 0-10 scale. The VAS score from 0-3 will be considered as mild, 4-7 as moderate and 8-10 as severe pain.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age 18 to 75 year of either sex
2. Musculoskeletal pain more than 3 months duration.
 
 
ExclusionCriteria 
Details  1.Acute trauma
2.Chronic musculoskeletal pain due to immunological disorders
3.Concurrent use of steroids in any form
4.Concurrent use any other homeopathic medicine for any other reason
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in pain relief in patients suffering from chronic musculoskeletal pain  1 week and then 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Quality of life, reduction in dose of rescue analgesic and reporting of any adverse effect during the study period  1 week followed by 4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/11/2021 
Date of Study Completion (India) 30/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  
Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Research Project on Pain 

1. Title of the Research Project:

Using Homeopathic Combinations for Treatment of Pain

Scientific Title: Evaluating the Efficacy of Homeopathic Combinations for the Treatment of Musculoskeletal Pain

2. Objectives:

Evidence based research for Assessment of Homeopathic Combinations in Treating the Musculoskeletal Pain.

3. Research Design & Methodology:

Non Randomised, Active Control Trial Using Homeopathic Combinations for Treatment of Musculoskeletal Pain.

Selection of Homeopathic Medicines- Existing Homeopathic Medicines covered in Materia Medica

Selection of Potencies                       - Tinctures & Potency

Selection of Pills Size                        - 20 Nos.

Selection of Dosage                           - 3 Pills

Frequency                                          - 4 Hourly

Days                                                    - 1 Week

Reviewed after 1 Month and 2 Months

4. Interventional Medicines:

Combination of Homeopathic Medicines which are already being used for treatment of different types of pain shall be used.

5. Anticipated Outcome(s):

Homeopathic Medicines can be used safely to treat the pain of the majority of people in absence of side effects because modern medicines if used for long duration have side effects.

These medicine have been effectively used to treat either singly or in combination with others, however scientific research / treatment protocols are required to substantiate the existing information. Efficacy of Homeopathic Medicines in various ailments if assessed shall boost the confidence  as it is very popular and being used across the Country however in absence of authenticated research/ data their role is questioned at different forums.

Since the earlier Research was successfully conducted in treatment of the COVID19 Fever and its effect on improving the respiratory distress.

This research shall instill confidence within the Homeopathic Professionals as they shall work under the guidance of Senior Allopathic Doctor as Principal Investigator. As the research/ data generated shall be in line with Scientific Research and beyond any doubts or questions.

 6. Name, Designation and Professional Qualifications and address of

Principal investigator:

Dr. Anil Agarwal

MBBS, MD, MNAMS, FICA, FIAPM

Professor & Head, Department of Anesthesiology,

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow 226 014

 

 Co-Investigator(s):

DR RK JAISWAL,  Assistant Professor

Department of Physiology & Biochemistry

National Homoeopathic Medical College & Hospital, Lucknow. 

17 years of Experience at different Academic Posts and as Examiner. 

Examiner:  Sarvpalli Radhakrishnan Ay University Jodhpur,  Kumau University Uttarakhand, Dehradoon Ay University Uttarakhand,  Dr. B. R. Ambedkar University Agra 

MEMBER OF Drug Proving Committee, HDRI (Homoeopathic Drug Research Institute), Lucknow. 

 Dr. Piyush Gupta

BSc, PGDIRPM, LLB, MA, Fellowship in Palliative Care, PhD

Fellow National Cancer Institute, National Institute of Health - USA

Secretary & Principal Executive Officer,

Cancer Aid Society, Lucknow 226001

 Dr Sandeep Khuba, MBBS, MD, PDCC

Assistant Professor, Dept. of Anaesthesiology,

SGPGIMS, Lucknow 226 014 

7. Details of the Institution submitting the research project

Name: Cancer Aid Society
Telephone: 9335166600

Postal address: 4th Floor, Sunshine Court Phase 2,

66C Prag Narain Road, Lucknow, U.P. - 226001
E-mail: piyushgupta@canceraidsocietyindia.org

8. Duration of Research Project: Two Months

 9. Brief concept of the project: (Not more than 200 words)

Cancer Aid Society received CSR Funding from NTPC in 2015 for establishment of Homeopathic Dispensary, ever since we have been working in Urban as well as Rural Settings for treatment of various acute and chronic diseases in general and Palliative Care to be specific. During last 5 years we used Homeopathic Interventions using combinations for effective treatment of Pain and Symptom Management. In spite of the fact that Homeopathy does not have any analgesics we could effectively treat various chronic pain with almost immediate action and mostly 50% relief within one week of treatment as measured through pain scale without using any Analgesics.  Similarly the combinations were effectively used for treatment of Arthritis, Migraine, Sinusitis, Tonsillitis, Laryngitis, Renal Stones, Chronic Constipation, Chronic Cough, Viral Fever etc. Patient interviews were obtained as documentary evidence.

Encouraged with the results of successfully conducted the clinical Trials on using the Homeopathic Combination for the Prophylaxis as well as Treatment of Viral Fevers/ COVID19 and associated respiratory distress this trial shall address the pain of the patients.

10. Protocol

This project shall use combinations of existing medicines for specific symptoms rather than the totality approach of Homeopathy.

Title: Evaluation of homeopathic combinations for the treatment of chronic musculoskeletal pain: a prospective, non randomized, open study

Research question: Does homeopathic combination improves pain and quality of life in patients suffering from chronic musculoskeletal pain?

Aims: To determine the efficacy of homeopathic combination for pain relief and improvement in quality of life in patients suffering from chronic musculoskeletal pain.

Primary objective: Improvement in pain relief in patients suffering from chronic musculoskeletal pain

Secondary objective: Improvement in Quality of life, reduction in dose of rescue analgesic and reporting of any adverse effect during the study period

Design of the study: Prospective, non randomized, active control trial

Study population: The patients in the age group of 18 to 75 years suffering from musculoskeletal pain more than 3 months duration.

Study sample: The patients attending pain clinic of hospital for complaint of musculoskeletal pain

Sample Size: 30 patients

Material & Methods:  Thirty patients attending pain clinic in the age group of 18-75 years with complaint of chronic musculoskeletal pain will be included in the study. Chronic musculoskeletal will be defined as musculoskeletal pain more than 3 months duration.

Informed consent will be taken from all patients enrolled in the study. The study will begin after approval from the Institute ethical committee. 

After enrollment in the study, the patients will be asked to stop any NSAIDS if they are taking for their musculoskeletal pain. 

The efficacy of the drug will be assessed with Visual analogue Scale (VAS) and RAND Short form-36 health related quality of life questionnaire (SF-36). The VAS score will be assessed from 0-10 scale. The VAS score from 0-3 will be considered as mild, 4-7 as moderate and 8-10 as severe pain. The SF-36 has 8 domains, with each domain score ranging from 0 -100.

Patients will be instructed to take rescue analgesic in the form of oral Tramadol (37.5 mg ) with Paracetamol ( 325 mg) combination ( Tab Ultacet, Jhonson & Johnson) if they perceive pain in moderate and severe category with maximum of 1 dose in a day. If rescue analgesic has been taken for 5 days at a stretch then patients will be advised to come for hospital visit.

The assessment for VAS score, SF-36 and dose of rescue analgesic will be done at 1 week, 1 month and 2 month after starting the study. 

Any adverse event during the study will be noted.

Data analysis: The continuous data will be presented as mean ± standard deviation and categorical data as frequency and percentage. 

Inclusion criteria

1.     Age 18 to 75 year of either sex

2.     Musculoskeletal pain more than 3 months duration.

Exclusion criteria

1.     Acute trauma

2.     Chronic musculoskeletal pain due to immunological disorders

3.     Concurrent use of steroids in any form

4.     Concurrent use any other homeopathic medicine for any other reason

    

 

 

Dr. Piyush Gupta

Secretary & Principal Executive Officer

Cancer Aid Society

Signature & Seal

Place: Lucknow  Date: 15-09-2021

 

 

 

 

 
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