The study is an open-label, randomized controlled, parallel group clinical trial conducted at the National Ayurveda Research Institute for Panchakarma (NARIP), Cheruthuruthy, Thrissur district, Kerala, India. The schedule of screening, enrollment, intervention, assessments, and follow-up visits in the clinical trial is shown in Table 4.

Participants in both groups will be admitted to the inpatient department of NARIP. Participants in the intervention group will receive the Ayurvedic treatment protocol, which includes madhutailika vasti for 7 days. As part of the treatment protocol, abhyanga (therapeutic massage) using tila taila will be performed by the medical team, followed by moist heat. Madhutailika vasti will then be administered through the anal route using sterilized equipment. The treatment will be administered from baseline to day 7. The participant will receive education about therapeutic massage with tila taila and will be asked to continue until day 30. The oral medications rasnasaptakam kwath, along with 1 g of shunti choorna (dried powder of Zingiber officinale Roscoe) and a 500-mg vatari guggulu tablet, will be given twice daily for 30 days from baseline.

The ingredients for madhutailika vasti and the sesame oil for therapeutic massage were manufactured at the Good Manufacturing Practices–certified pharmacy at NARIP. The rasnasaptakam kwath powder, shunti choorna powder, and vatari guggulu tablet were manufactured by Indian Medicinal Pharmaceutical Corporation Ltd, Uttarakhand, India, in accordance with the respective standards specified in the Ayurveda Pharmacopoeia of India [19].

Participants in the control group will receive physiotherapy with pelvic traction, adjusted according to the participant’s body weight, for 8 to 9 hours using either a continuous or intermittent method based on the severity of pain. Additionally, a Gabaneuron tablet (300 mg) will be administered twice daily for 30 days from baseline, and diclofenac gel will be applied externally for 30 days. A diclofenac sodium tablet (50 mg-75 mg) will be administered, as advised by a coinvestigator (a practitioner of conventional medicine) or the conventional medicine consultant at NARIP, for a maximum period of 7 days, depending on the severity of pain. Participants will be advised to take the diclofenac sodium tablet only when painful episodes occur during the follow-up period. A pantoprazole tablet (40 mg) will also be advised whenever a diclofenac sodium tablet is administered. The details of the interventions in both groups are shown in Table 5.

Changes in the numeric pain rating scale, visual analog scale (VAS) score, and the ODI (version 2.0) score will be assessed as the primary outcome measures. These outcomes will be assessed at baseline (day 1) and on day 8 (after completing IP treatment), day 30, and day 60. The investigators will ask the patients to rate their pain intensity at each visit using a 0 to 10 numeric pain rating scale. The investigators will also record the ODI score using the ODI (version 2.0) during screening. The investigators will instruct the participants on how to fill out each question.

The secondary outcome measure is quality of life, assessed using the 36-item Short Form Health Survey (SF-36) at baseline and on day 8, day 30, and day 60. The occurrence of adverse events (AEs) and the need for rescue analgesic medication, if any, will be recorded on day 8, day 30, and day 60.

During each follow-up visit, the investigator will seek information on AEs, which will be recorded in the case report form (CRF), and appropriate treatment will be provided. Any serious adverse event (SAE) that occurs after the study period and is considered possibly related to the study treatment will be recorded and reported immediately.

Participants who wish to withdraw from the study for any reason, or who demonstrate any noncompliance, will be withdrawn from the study. Participants will also be withdrawn if a suspected adverse drug reaction, AE, or SAE is confirmed by a causality assessment to be related to the trial intervention. If, during the study, a participant meets any of the exclusion criteria (either newly developed or not previously recognized), the participant will be withdrawn from the study. The reasons for withdrawal will be recorded in the participant’s CRF.

The sample size for this trial is 80 participants. A previously published study reported a mean change of 5 points in the ODI score from baseline after treatment in the control group [20]. We hypothesized that the intervention group would have a 10-point change in ODI score from baseline after treatment. With an SD of 7 points, 31 participants in each group will be needed to detect the difference with 80% power and 95% CI. Because the sample size estimated using the ODI was larger and more conservative compared to the other coprimary outcome measures, it was considered sufficient to provide adequate statistical power for primary outcomes. Adding an attrition rate of 25%, the sample size becomes 40. Therefore, a total of 80 patients will be enrolled in the trial (40 in each group).

Participants presenting with features of lumbar radiculopathy at the outpatient department of NARIP will be screened for eligibility to participate in the clinical trial. The written informed consent of the patients will be obtained before screening. Participants with an ODI score of 21% to 60% will undergo MRI of the lumbosacral spine to confirm the diagnosis. A hemogram, liver function test (LFT), renal function test (RFT), and testing for C-reactive protein (CRP), hemoglobin A_1c, random blood sugar, rheumatoid factor, and human leukocyte antigen (HLA) B27 will be performed at screening. The data will be entered into the CRF for screening, and on day 60, hemogram, LFT, RFT, and CRP will be performed.

The trial is designed as a single-center, open-label, randomized controlled clinical study. Eligible participants will be randomized to the intervention or control group using a randomized block design. Allocation concealment will be achieved using sequentially numbered opaque sealed envelopes, which were prepared by an individual not involved in participant recruitment. The envelopes were identical, opaque, properly sealed, and sequentially numbered to prevent prediction of group allocation. They were stored securely and opened sequentially only after participant enrollment. We have also clarified the procedures followed to maintain the integrity and verification of the concealment process throughout the study.

The details of the study procedure are presented in Figure 1.

A compliance assessment form will be provided to participants to monitor adherence to the prescribed medicines at each visit. Participants will be instructed to complete the assessment form after each administration of medicine. The completed forms will be collected during follow-up visits.

Participants will be asked to inform the investigators about any concomitant medications they are taking. The investigators will record the details of such medicines and the reason for taking them in the CRF. If there is any medical emergency, rescue medicines can be used, and the details will be recorded in the CRF.

The investigators and the research team will be trained in Good Clinical Practice (GCP) protocols, trial-specific process, and documentation before commencing the study. The research team will collect the information, and the details will be filled in the CRF (Figure 1). All the documented data entered by the team will be checked regularly by the principal investigator (PI) or coinvestigators. Any modifications or corrections made will be made clearly visible, and the corrections will be signed and dated by the PI or coinvestigator. The data will subsequently be entered in an electronic format of CRF and verified as and when required. The original CRF will be archived.

The collected data will be checked for accuracy and completeness prior to analysis. Categorical variables will be presented as number (percentage) and compared between groups using the chi-square test or Fisher exact test, as appropriate. Continuous variables will be expressed as mean (SD) for normally distributed data or median (IQR) for nonnormally distributed data. Normality will be assessed using probability plots and the Shapiro-Wilk test. The primary analysis of repeated outcome measurements across follow-up visits will be performed using repeated-measures ANOVA for normally distributed continuous variables. In case of violation of normality assumptions or for correlated nonnormal outcomes, generalized estimating equation (GEE) models with appropriate link functions and working correlation structures will be applied. The analysis model will include treatment group, time, and group×time interaction effects to assess differential treatment responses over time.

Between-group comparisons at individual time points will be performed using an independent 2-tailed t test or Mann-Whitney U test, while within-group changes will be analyzed using a 2-tailed paired t test or Wilcoxon signed-rank test, depending on data distribution. Missing data and dropouts will be managed using an intention-to-treat approach, wherever feasible. For repeated-measures analyses using GEE models, all available observations will be used under the assumption of missing at random. The reasons for dropout or missing observations will be documented and reported. Sensitivity analyses may also be performed to assess the impact of missing data on study outcomes. A 2-sided P value of <.05 will be considered statistically significant. Statistical analysis will be performed using Stata/MP (version 16.1; StataCorp).

The sponsor will set up a monitoring committee, which will conduct virtual and on-site monitoring to ensure adherence to the clinical trial protocol and compliance with GCP guidelines and the research policy of the Central Council for Research in Ayurvedic Sciences.

The regulatory authorities, the institutional ethics committee (IEC), or the funding agency will audit the trial, and the research team will ensure access to all the documents related to the study for the on-site audit.

The study was approved by the IEC of NARIP (F. No. 8/16/23/NARIP/Tech meeting/2509; dated March 31, 2023) and has been registered prospectively at the Clinical Trial Registry of India (CTRI/2023/05/052859). The study will be conducted in accordance with the Indian Council for Medical Research National Ethical Guidelines for Biomedical and Health Research on Human participants (2017). Written informed consent (either in English or Malayalam) will be obtained from eligible participants before screening. All protocol modifications will be shared with the IEC and funding agency and will be implemented in the study after the IEC approval. The CRFs will be stored in a secure area and will ensure confidentiality. Routine medical care will be given to study participants, if required, after the completion of study period. The study participants will be compensated with an incidental support of Rs 100 (US $1.05 as of August 25, 2026) for each visit. The study participants are insured under clinical trial insurance.

Lumbar disc herniation frequently occurs at the L4-L5 or L5-S1 levels, and radicular pain is one of the most common and disabling symptoms [21-24]. The study described here will compare an Ayurvedic treatment protocol to standard care for lumbar disc herniation with radiculopathy, including pelvic traction, oral medication, and topical medication.

Conventional pharmacological management of lumbar disc herniation with radiculopathy includes NSAIDs such as diclofenac and neuropathic agents such as gabapentin. While NSAIDs effectively reduce inflammatory pain, their impact on neuropathic pain is limited [25]. Gabapentin may reduce radicular pain but can cause AEs [26]. Topical diclofenac gel application causes significant reduction in pain; however, its use is associated with local AEs such as skin irritation [27,28].

Although mechanical traction is commonly used and can effectively relieve lumbar and leg pain and improve ODI scores, it has no significant effect on spinal mobility. Its beneficial effects on pain relief are observed when added to medication or bed rest, but its long-term benefits remain inconsistent [29]. Furthermore, systematic reviews indicate that the overall quality of evidence supporting traction is limited, highlighting the need for further comparative evaluation [30]. Ayurvedic management of lumbar radiculopathy includes internal medications, external therapies, and panchakarma procedures [31]. Preliminary evidence suggests that the proposed Ayurvedic intervention, namely rasnasaptakam kwath, exhibits anti-inflammatory activity [32]. Vatari guggulu contains guggulu as a key ingredient, and pharmacological studies have demonstrated that guggulu possesses significant anti-inflammatory and analgesic properties by inhibiting inflammatory mediators and modulating cytokine pathways [33]. Oil massage and therapeutic steaming are well-established Ayurvedic therapies for promoting well-being [34]. As grudhrasi is considered a vatavyadhi, vasti karma is regarded as the most suitable panchakarma therapy.

This randomized clinical trial will evaluate the efficacy of Ayurvedic treatment protocol for lumbar disc herniation with radiculopathy in comparison with standard care. The measures used in this clinical trial will yield valid data for the treatment of lumbar disc herniation with radiculopathy.

The study is being conducted at a single center; therefore, participants may be recruited from a single geographical location. The findings are expected to be applicable to countries where Ayurveda is practiced. Hence, the outcomes of this study cannot be generalized. However, regulatory approval for use of the Ayurvedic treatment and availability of trained personnel will be essential. The study is being conducted as an open-label trial because blinding is not feasible for a multimodal Ayurvedic inpatient intervention. As the primary outcomes (VAS, ODI, and SF-36) are patient reported, they may be influenced by treatment expectations, preferences, and attention effects. To reduce bias, outcome assessments will be performed by an independent blinded assessor. Future double-blind randomized trials incorporating objective measures such as MRI findings or biomarkers are recommended to validate these results.

The outcome of this trial may provide scientific evidence regarding the safety and efficacy of the Ayurvedic treatment protocol in lumbar disc herniation with radiculopathy. The study may also contribute to the development of evidence-based integrative management strategies and standardized treatment protocols for this condition.