Evaluating the Efficacy of Homeopathic Combinations for the Treatment of Musculoskeletal Pain

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 Trialsonusing 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