CTRI

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CTRI Number

CTRI/2025/01/079258 [Registered on: 23/01/2025] Trial Registered Prospectively

Last Modified On:

06/02/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Other (Specify) [Sairub Diaba Neuro Pain Oil, Diaba Care & Pain Balm- (T2DM) with Peripheral Neuropathy]

Study Design

Single Arm Study

Public Title of Study

Study to Assess the Effectiveness and Safety of Sairub Heal Diaba Care, Sairub Diaba Neuro Pain Oil, and Sairub Heal Pain Balm in Treating Nerve Pain in Type 2 Diabetic Patients.

Scientific Title of Study

An Open-Label, Single-Arm, Single-Centered Clinical Study To Evaluate The Efficacy And Safety Of Sairub Heal Diaba Care, Sairub Diaba Neuro Pain Oil, And Sairub Heal Pain Balm In Type 2 Diabetic Patients With Peripheral Neuropathy

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
CTSRS/2422 Version No. 1.0 Dated 21/Nov/2024	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Sambashiva
Designation	Principal Investigator
Affiliation	Sri Lakshmi Super Speciality Hospital
Address	#301, Ground Floor, 3rd Main Road, Old Extension, KR Puram, Bangalore KARNATAKA 560036 India
Phone	06364898825
Fax
Email	drsambashiva.sl@gmail.com

Details of Contact Person
Scientific Query

Name	Ms Sathyavathi LM
Designation	HOD-Clinical Operations
Affiliation	Samahitha Research Solutions
Address	Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore Bangalore Bangalore KARNATAKA 560069 India
Phone	9739001749
Fax
Email	satyalm@samahitha.com

Details of Contact Person
Public Query

Name	Ms Arpita Malgi
Designation	Team Lead - Clinical Operations
Affiliation	Samahitha Research Solutions
Address	Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore Bangalore Bangalore KARNATAKA 560069 India
Phone	06364898825
Fax
Email	arpita@samahitha.com

Source of Monetary or Material Support

Saisa Medi LLP, Plot No: 5-6, Sector 3, Industrial Area, Parwanoo, District : Solan 173220, Himachal Pradesh.

Primary Sponsor

Name	Saisa Medi LLP
Address	Plot No 5 6, Sector 3, Industrial Area, Parwanoo, District Solan 173220, Himachal Pradesh.
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sambashiva	Sri Lakshmi Super Speciality Hospital	#301 3rd main road, Old Extension KR Puram, Banglore-560036 Bangalore KARNATAKA	6364898825 drsambashiva.sl@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Pranav Diabetes Center Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E114\|\|Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Sairub Heal Diaba Care, Reference: NA, Route: Oral, Dosage Form: Taila, Dose: 9(drops), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -Take 9 drops of Sairub Heal Diaba Care under the tongue three times a day: morning on an empty stomach, and afternoon and night 30 minutes before food. Avoid eating or drinking for 15 minutes before and after taking it.
2	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Sairub Diaba Neuro Pain Oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Apply Sairub Diaba Neuro Pain Oil once daily in the morning to the affected area, including the navel and abdomen. After applying, use medium-hot fermentation (like a warm compress) for 15 minutes to improve absorption and effectiveness.
3	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Sairub Heal Pain Balm, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -Apply a thin layer of balm to the affected area once daily, at night. Gently massage until absorbed.

Inclusion Criteria

Age From	30.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	1. Male or female participants aged between 30 and 75 years. 2. Participants with elevated fasting blood sugar levels greater than 126 mg/dl and random blood sugar levels greater than 140 mg/dl. 3. Participants diagnosed with Type 2 Diabetes Mellitus (T2DM) according to the diagnostic criteria set by the World Health Organization (WHO). 4. HbA1c levels greater than 7%. 5. Diagnosis of peripheral neuropathy confirmed using the Douleur Neuropathique 4 (DN4) questionnaire. 6. Pain intensity score greater than or equal to 4 on the Numeric Pain Rating Scale (NPRS) in the past week. 7. Participants experiencing daily neuropathic pain for at least 6 months. 8. Use of insulin therapy or oral hypoglycemic agents, other than metformin. 9. Participants must have the ability and willingness to provide written informed consent. 10. Participants must be willing to comply with the study protocol, which includes regular sublingual administration, fasting requirements, application of investigational products, and attending all scheduled study visits.

ExclusionCriteria

Details

1.History of severe comorbid conditions, including:
Cardiovascular diseases.
Hepatic dysfunction.
Renal dysfunction.
2. Known hypersensitivity or allergic reactions to any ingredients in the investigational products.
3. Pregnant or lactating women.
4. Participation in any other clinical trial within 30 days prior to screening.
5. History of neurological disorders unrelated to diabetic peripheral neuropathy, such as multiple sclerosis or stroke.
6. Presence of mononeuropathy or other causes of neuropathy, including vitamin B12 deficiency, hypothyroidism, or alcohol-related neuropathy.
7. Current or recent treatment with systemic corticosteroids, anticonvulsants, or antidepressants specifically for neuropathic pain management.
8. History of severe psychiatric illnesses, including major depression, schizophrenia, or any other serious mental health conditions.
9. Any other condition, at the discretion of the investigator, that may interfere with the conduct or interpretation of the study results, including but not limited to cognitive impairments or medical conditions that require ongoing management during the study.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome

TimePoints

The Glycemic Control
1. Reduction in HbA1c levels from baseline to Day 90.
2. Improvement in fasting blood sugar (FBS) and random blood sugar (RBS) levels from baseline to Day 90.
Neuropathy and Pain Management
1. Reduction in pain intensity as measured by the Numeric Pain Rating Scale (NPRS) from baseline to Day 90.
2. Improvement in neuropathic symptoms as assessed by the Neuropathic Pain Symptom Inventory (NPSI) from baseline to Day 90.

Day 0, Day 30, Day 60 and Day 90

Secondary Outcome

Outcome	TimePoints
1.Quality of Life Improvement 2.Improvement in Sleep Quality 3. Safety and Tolerability 4. Compliance with Treatment	Day 0, Day 30, Day 60 and Day 90

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100"

Phase of Trial

Phase 3

Date of First Enrollment (India)

03/02/2025

Date of Study Completion (India)

27/08/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="3"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary
Modification(s)

BACKGROUND & INTRODUCTION

Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by hyperglycemia resulting from insulin resistance and impaired insulin secretion. Over time, uncontrolled diabetes can lead to systemic complications, including peripheral neuropathy, which affects approximately 50% of diabetic patients. Diabetic peripheral neuropathy (DPN) is associated with chronic pain, numbness, tingling sensations, and reduced quality of life. Additionally, uncontrolled hyperglycemia exacerbates nerve damage and systemic inflammation, compounding the challenges faced by patients.

Sairub Heal Diaba Care, Sairub Diaba Neuro Pain Oil, and Sairub Heal Pain Balm are proprietary Ayurvedic formulations designed to address both the systemic and localized complications of T2DM. These products aim to improve glycemic control, alleviate neuropathic symptoms, and enhance overall patient well-being.

PURPOSE OF THE STUDY

This study aims to evaluate the effectiveness and safety of Sairub Heal Diaba Care, Sairub Diaba Neuro Pain Oil, and Sairub Heal Pain Balm in managing diabetic peripheral neuropathy in patients with Type 2 Diabetes Mellitus. The primary goals are to assess improvements in glycemic control, reduction of neuropathic pain and symptoms, enhancement of quality of life, and confirmation of the safety of these Ayurvedic formulations.

Result of the study:

A total of 100 subjects with type 2 diabetes mellitus and peripheral neuropathy were enrolled in the study. Out of 100 enrolled subjects 98 completed the study and 2 subjects were lost to follow up.

The mean age of the participants was 37.2 years. Both male and female subjects were included in the study. The mean body mass index reduced from baseline to the end of study.

Primary Outcome Results

There was a significant improvement in glycemic control from baseline to end of study.
Mean HbA1c levels reduced from 8.25 at baseline to 6.08 at Day 180.
Fasting blood sugar levels reduced from 152.16 mg per dL at baseline to 129.69 mg per dL at Day 180.
Random blood sugar levels reduced from 209.32 mg per dL at baseline to 164.12 mg per dL at Day 180.

Neuropathic pain intensity showed marked reduction during the study period.
The mean Numeric Pain Rating Scale score reduced from 8 at baseline to 2 at Day 180.
Neuropathic Pain Symptom Inventory scores showed improvement in spontaneous pain evoked pain sensory disturbances duration of pain and frequency of pain attacks from baseline to end of study.

Secondary Outcome Results

Quality of life assessed using SF 36 questionnaire showed improvement across all domains including physical functioning energy emotional well being social functioning pain and general health by the end of the study.

Sleep quality improved during the treatment period. The mean sleep interference score reduced from 8 at baseline to 2 at Day 180 indicating reduced pain related sleep disturbance.

Safety Results

The study products were well tolerated. No serious adverse events were reported during the study. All reported adverse events were mild and resolved without medical intervention. Laboratory parameters and vital signs remained within normal limits throughout the study.

Conclusion

The study demonstrated that Sairub Heal Diaba Care Sairub Diaba Neuro Pain Oil and Sairub Heal Pain Balm are safe and effective in improving glycemic control reducing neuropathic pain and improving quality of life in patients with type 2 diabetes mellitus and peripheral neuropathy.