| CTRI Number |
CTRI/2026/01/101697 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see which Ayurvedic herbal wash (Nimbapathradi dhara or Saribaneeli dhara) best heals spider poison symptoms in patients with swelling, pain, itching, discoloration, vesicles, burning sensation and oozing |
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Scientific Title of Study
|
A comparative clinical trial to evaluate the efficacy of nimbapatradi dhara against saribaneeli dhara in lutha visha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswathy Ravi |
| Designation |
2nd year pg scholar |
| Affiliation |
Parassinikkadavu Ayurveda Medical college |
| Address |
1st floor, Department of Agadatantra, Parassinikkadavu Ayurveda Medical college
Parassinikkadavu
Kannur
KERALA
670563
India |
| Phone |
9496277883 |
| Fax |
|
| Email |
aswathyekm007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayasmitha S J |
| Designation |
Professor |
| Affiliation |
Parassinikkadavu Ayurveda Medical college |
| Address |
Professor, Dept of Agada Tantra, Parassinikkadavu Ayurveda Medical college
Parassinikkadavu
Kannur
KERALA
670563
India |
| Phone |
8714498512 |
| Fax |
|
| Email |
dr.jayasmitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aswathy Ravi |
| Designation |
2nd year pg scholar |
| Affiliation |
Parassinikkadavu Ayurveda Medical college |
| Address |
1st floor, Department of Agadatantra, Parassinikkadavu Ayurveda Medical college
Parassinikkadavu
Kannur
KERALA
670563
India |
| Phone |
9496277883 |
| Fax |
|
| Email |
aswathyekm007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
2nd year PG scholar, department of Agata tantra, Parassinikkadavu Ayurveda Medical college, Parassinikkadavu |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aswathy Ravi |
Pappinisseri visha chikilsa kendram, Agadatantra speciality hospital |
OPD No 1, Department of agadatantra, Pappinisseri P.O
Kannur
KERALA |
9496277883
aswathyekm007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVR AYURVEDA MEDICAL COLLEGE PARASSINIKKADAVU INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T633||Toxic effect of venom of spider. Ayurveda Condition: LUTAVISHA-ADHISHTHANAJANYAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pariShekaH (viShopakramaH), परिषेकः (विषोपक्रमः) | (Procedure Reference: Charaka samhita, Procedure details: External application of 380 ml of Nimbapathradi decoction from a distance of 12 angula height as dhara for 30 minutes, twice daily on the affected part of the body along with Lodrasevyadi kashayam internally)
(1) Medicine Name: Nimbapathradi, Reference: Kriyakoumudi, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 380(ml), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | pariShekaH (viShopakramaH), परिषेकः (विषोपक्रमः) | (Procedure Reference: Charaka Samhita, Procedure details: External application of 380 ml of Saribaneeli decoction from a distance of 12 angula height as dhara for 30 minutes, twice daily on the affected part of the body along with Lodrasevyadi kashayam internally)
(1) Medicine Name: Saribaneeli, Reference: Prayogasamuchayam, Vishavaidya Jyothsnika, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 380(ml), Frequency: bd, Duration: 7 Days |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical signs of lutha visha, participants presenting with two or more symptoms, with written informed consent |
|
| ExclusionCriteria |
| Details |
Spider pisoning with systemic manifestations, pregnant or lactating women, chronic comorbidities (uncontrolled diabetes/renal/hepatic failure etc.) , patient who has undergone any other treatment for same symptoms |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in Symptom Scale scores for Pain, swelling, erythema, vesicles, itching, exudation and burning sensation are quantifies by Vision Analog Scale, Total severity scale |
On 0 (Before treatment),
8th day (After treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Frequency and severity of adverse events (AEs),
Use of rescue medications or unscheduled additional therapies, if any,
Patient satisfaction score on Day 8 using a Visual Analog Scale (0–10). |
On 0 (Before treatment),
8th day (After treatment) |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This clinical trial is designed as a randomized, single-blind, comparative study to investigate the therapeutic efficacy and safety of Nimbapathradi Dhara in the management of Lutha Visa, commonly known as spider envenomation. In the field of Agadatantra, spider bites are recognized as a significant cause of localized tissue reactions, including pain, swelling, and necrosis, yet specific antivenom treatments remain unavailable in many clinical settings. The study aims to evaluate a classical Ayurvedic formulation, Nimbapathradi Dhara—comprising Azadirachta indica, Pongamia pinnata, and Curcuma longa against the established standard of Saribaneeli Dhara.
The trial will involve 56 participants, aged between 18 and 60 years, who present with diagnostic signs of spider poisoning such as discoloration, vesicles, itching, and burning sensations within 72 hours of the bite. These participants will be randomly allocated into two equal groups of 28 individuals each. Both groups will receive a standardized internal administration of Lodhrasevyadi Kashaya, an herbal decoction, twice daily. The primary distinction between the groups lies in the external intervention: the trial group will receive Nimbapathradi Dhara, while the control group will receive Saribaneeli Dhara. The Dhara procedure involves pouring the lukewarm medicated decoction over the affected area for 30 minutes twice daily over a 7-day treatment period.
The primary objective is to compare the reduction in clinical symptoms between the two formulations, while secondary objectives include assessing the safety profile and the time required for complete symptom resolution. Clinical assessments will be conducted on the 1st, 3rd, 5th, and 7th days of treatment, with a final follow-up on the 8th day. Symptoms such as pain, itching, and burning sensations will be quantified using the Visual Analog Scale (VAS), while erythema, swelling, and exudation will be measured using the Total Severity Score (TSS).
The data collected will undergo statistical analysis using SPSS. Continuous variables will be analyzed using the independent t-test or the Mann-Whitney U test depending on the distribution of the data, with a significance level set at p less than 0.05. By scientifically documenting the efficacy of Nimbapathradi Dhara, this research seeks to validate an accessible and cost-effective Ayurvedic treatment protocol that could be integrated into public health management for spider bites, particularly in endemic regions like Northern Kerala. The study will be conducted at the Pappinissery Visha Chikitsa Kendram under the MVR Ayurveda Medical College, ensuring adherence to ethical guidelines and institutional oversight.
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