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| LETTER TO EDITOR |
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| Year : 2019 | Volume
: 7
| Issue : 4 | Page : 256-257 |
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Need for publishing study protocols of research in Ayurveda
Jyothy K Bhaskaran, Srihari Sheshagiri
Department of Kaumarabhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre, Datta Meghe University of Health Sciences (DU), Wardha, Maharashtra, India
| Date of Submission | 16-Mar-2020 |
| Date of Decision | 17-Mar-2020 |
| Date of Acceptance | 17-Mar-2020 |
| Date of Web Publication | 14-Apr-2020 |
Correspondence Address:
Dr. Jyothy K Bhaskaran
Department of Kaumarabhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre, Datta Meghe University of Health Sciences (DU), Wardha 442001, Maharashtra
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/JISM.JISM_19_20
How to cite this article:
Bhaskaran JK, Sheshagiri S. Need for publishing study protocols of research in Ayurveda. J Indian Sys Medicine 2019;7:256-7 |
Dear Editor,
Development of any science depends on the quality of research conducted. Scientific research works require critical appraisal to produce genuine data. Peer-reviewed protocol publication is a new arena of publication, wherein the protocol (synopsis) of the proposed research work or ongoing work of which final data have not been evaluated or assessed is published (as an article). The protocol (synopsis) publication contains all the information of the proposed or ongoing trial, wherein the objectives, research question, hypothesis, methodology of conduction of the study, method of assessment of outcomes, and its probable translational components are briefed as per the guidelines used and based on the type of the trial.
| Advantages | |  |
The main benefits of protocol publication are that the proposed works get reviewed by the experts in the corresponding field. It is a novel way to understand and mitigate the shortcomings of the proposed research works, which the researcher would have faced during or after completion of the proposed research work. It would also help in the reduction of unintentional duplication of research works and their publications, thereby saving the time and efforts of the researchers.
Selective publication of only positive results by avoiding others can be avoided as the study protocol already published would contain all the expected outcomes at defined timeline.
To add to it, protocol publications would be helpful in applying for grants from funding agencies, once those have been published after a thorough peer review in standard journals, inculcating the view of external experts.
The publication of protocols also helps in the promotion of collaborative research works in the proposed areas. Once the protocols have been published, it would help future publication of the trial outcomes in high-impact journals in a faster manner as the peer reviewers would not require to reassess the methodology of the research work, which is already peer reviewed and published.
It may further be noted that in journals such as Annals of Internal Medicine, publication of protocols is the mandatory requirement for publishing the subsequent research outcomes.[1] Many journals, such as BMC Public Health, JMIR, Methods and Protocols, Natures Protocols, and Journal of Clinical Trials, etc publish protocols, and they have defined instructions of preparing the same. The journal Nature Protocols accepts only proven protocols, and it does not accept novel primary protocols unless the methodology used to generate the results is published elsewhere in a peer-reviewed journal.
Primary requisites for the publication of protocols are as follows:
- Preparation of protocols as per the guidelines of EQUATOR guideline checklist such as PRISM-P (Preferred Reporting Items for Systematic review and Meta-analysis Protocols) and SPIRIT (Standard Protocol Items for Randomized Trials)[2]
- Clearance of the study from the respective ethics committee
- Registration of the trials in the respective trial registration boards such as Clinical Trial Registry of India (CTRI)
| In Ayurveda | | |
Systematic research in Ayurveda has a history of 70 years,[3] with the establishment of first Ayurveda research institute at Jamnagar, Gujarat, India, in 1953. Simultaneously, publication of research works also had started with very few journals and magazines. In the last 15–20 years, publication of articles has seen a rapid increase. In a way, the Ayurveda research community has slowly started getting into the culture of publishing their work, albeit deficient in quality, which would come in due course of time.
An overview on protocols published in PubMed fetched only seven protocols on Ayurveda research[4],[5],[6],[7],[8],[9],[10] and one in research on Yoga.[11] Publishing protocols of research works in Ayurveda, would definitely give the necessary impetus to strengthen the validity of the science through structured research works avoiding repetitions, errors, and bias in study designs. It would also help in monitoring the research works to avoid deviation from the protocol, thereby ensuring ethical standards of research and safety of the participants. With increasing number of Ayurveda colleges offering postgraduate and doctoral courses all over India,[12] there is a drastic increase in the number of research works conducted. The most common problem faced by all researchers is the lack of a solid source of information about ongoing and planned studies, because of which many a times similar research works are repeated unintentionally. Hence, protocol publication could definitely help in accessing the information of such research works.
The future of publication process, envisaged in [Figure 1], would be an ideal step in improving the quality of the research works and publications in Ayurveda, wherein scientific validity of the works would not be questioned at a later stage and the results of would be better accepted by the scientific community.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | Why should I publish my protocol or grant proposal? Available from: https://support.jmir.org/hc/en-us/articles/115002860428-Why-should-I-publish-my-protocol-or-grant-proposal-. [Last accessed on 2020 Mar 15]. Cited on 2020 Jan 10.  |
| 2. | Study Protocols. Available from: https://journals.lww.com/md-journal/Pages/studyprtocols.aspx. [Last accessed on 2020 Mar 13]. Cited on 2020 Jan 10. |
| 3. | Nishteswar K. 2013—Diamond jubilee year of research in Ayurveda. Ayu 2013;34:233-4. [ PUBMED] [Full text] |
| 4. | Nagoba B, Davane M. Studies on wound healing potential of topical herbal formulations—Do we need to strengthen study protocol? J Ayurveda Integr Med 2019;10:316-8. |
| 5. | Tonde SS, Gandhi M, Patil YR. Prevalence of Shukra vega dharana in an Indian population: A cross sectional survey protocol. J Ayurveda Integr Med 2019;10:119-25. |
| 6. | Chaudhury RR. A clinical protocol for the study of traditional medicine and human immunodeficiency virus-related illness. J Altern Complement Med 2001;7:553-66. |
| 7. | Witt CM, Michalsen A, Roll S, Morandi A, Gupta S, Rosenberg M, et al. Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee—Study protocol for a randomized controlled trial. Trials 2013;14:149. |
| 8. | Varker KA, Ansel A, Aukerman G, Carson WE 3rd. Review of complementary and alternative medicine and selected nutraceuticals: Background for a pilot study on nutrigenomic intervention in patients with advanced cancer. Altern Ther Health Med 2012;18:26-34. |
| 9. | Dahanayake JM, Perera PK, Galappaththy P, Samaranayake D. Efficacy and safety of two Ayurvedic dosage forms for allergic rhinitis: Study protocol for an open-label randomized controlled trial. Trials 2020;21:37. |
| 10. | Elder C, Aickin M, Bauer V, Cairns J, Vuckovic N. Randomized trial of a whole-system Ayurvedic protocol for type 2 diabetes. Altern Ther Health Med 2006;12:24-30. |
| 11. | Dhungana RR, Khanal MK, Joshi S, Kalauni OP, Shakya A, Bhrutel V, et al. Impact of a structured yoga program on blood pressure reduction among hypertensive patients: Study protocol for a pragmatic randomized multicenter trial in primary health care settings in Nepal. Bmc Complement Altern Med 2018;18:207. |
| 12. | AYUSH Admissions Central Counseling Committee (AACCC). https://aaccc.gov.in/aacccpg/Home/GetInstituteProfile. [Last accessed on 2020 Mar 14]. Cited on 2019 Jan 10. |
[Figure 1]
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