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CTRI Number  CTRI/2025/06/088922 [Registered on: 16/06/2025] Trial Registered Prospectively
Last Modified On: 25/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of Herbal Unani Medicine for Numbness and Tingling Sensation in Diabetic Patients. 
Scientific Title of Study   Efficacy of Kalonji(Nigella sativa) in Diabetic Neuropathy- a Randomised Placebo Control Study. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mufasira Fathima B 
Designation  PG Scholar 
Affiliation  Government Unani Medical College , Chennai 
Address  OP no 5M, Department of PG Moalajat, Arignar Anna Government Hospital of Indian Medicine, Arumbakkam, Chennai
Arignar Anna Govt. Hospital of Indian Medicine Campus, Arumbakkam, Chennai - 600106
Chennai
TAMIL NADU
600106
India 
Phone  8778184399  
Fax    
Email  drmufasirafathima@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mubasheera Begum  
Designation  Professor  
Affiliation  Government Unani Medical College Chennai 
Address  OP no 5M Arignar Anna Hospital of Indian Medicine, Arumbakkam, Chennai
Arignar Anna Govt. Hospital of Indian Medicine Campus, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India 
Phone  9841620486  
Fax    
Email  muskaan.m@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mubasheera Begum  
Designation  Professor  
Affiliation  Government Unani Medical College Chennai 
Address  OP no 5M Arignar Anna Hospital of Indian Medicine, Arumbakkam, Chennai
Arignar Anna Govt. Hospital of Indian Medicine Campus, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India 
Phone  9841620486  
Fax    
Email  muskaan.m@gmail.com  
 
Source of Monetary or Material Support  
State government, Govt of TamilNadu, Government Unani Medical College, Arumbakkam, Chennai 600106 
 
Primary Sponsor  
Name  Government of TamilNadu 
Address  Government Unani Medical College, ARUMBAKKAM, CHENNAI-600106 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Mufasira Fathima  Arignar Anna Government Hospital of Indian Medicine  OP No 5M Department of PG Moalajat, Government Unani Medical College, ARUMBAKKAM, CHENNAI-600106
Chennai
TAMIL NADU 
8778184399

drmufasirafathima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethics Committee (IEC) for Unani Medical Research for PG Scholars of M.D.(Unani)  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kalonji (Nigella sativa)  powdered kalonji in capsules 500mg - 2capsules thrice a day Oral route for 6weeks 
Comparator Agent  Wheat flour  500 grams capsule 2capsules thrice a day for 6 weeks 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Presence of type 2 diabetes mellitus
Type 2 DM patients diagnosed with DPN for at least one month and blood glucose stabilized with antidiabetic medications were included in the study.
Symptoms such as numbness, tingling sensation, burning pain, excruciating stabbing type of pain, paraesthesia, and hyperesthesia coupled with deep aching in feet or hands.
Impaired pinprick, temperature or vibration sensation in both feet and absent or reduced
ankle reflexes.
HbA1C Levels less than 11percent
Ability to provide informed consent and comply with study procedures.
Diabetic Neuropathy Symptom score (DNS Score more than 1) 
 
ExclusionCriteria 
Details  HbA1C More than 11 percent
History of allergy or intolerance to kalonji or any of its components
Other complications like Nephropathy and Retinopathy.
Use of medications known to significantly affect nerve function (e.g., chemotherapeutic
agents, immunosuppressants).
Diabetic patients with serious acute and chronic complications, such as diabetic ketoacidosis, etc
Pregnancy or lactation women
They had a severe illness in one of their vital organs such as their livers or kidneys (GFR less than 30 ml per min) or other organs.
Unstable, bedridden and mentally retarded patients.
Alcohol abusers and drug addicts.
Neuropathic pain is not caused by PDN (e.g., malignant tumours, vitamin B12 deficiency, hypothyroidism, neurotoxic drug therapy, etc) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of kalonji in improving in
Signs and symptoms of Diabetic Neuropathy based on severity in Neuropathy Disability Score.
 
Baseline, 1st week ,2nd week, 4
th week , 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effects of kalonji (Nigella sativa) on changes in Michigan
Neuropathy Screening Instruments (MNSI) and Vibration Perception Threshold (VPT)
 
Baseline, 1st week ,2nd week, 4
th week , 6th week 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   30/06/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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)  
Diabetic Neuropathy (DN) is the most common microvascular complication that occurs in both type 1 and type 2 diabetes. Diabetic Peripheral Neuropathy (DPN) has been defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes. It is a kind of neurodegenerative disease of the peripheral nerves that primarily affects autonomic, sensory, and eventually, to a lesser degree, motor axons. 
The most common form of diabetic neuropathy is Distal Symmetric Polyneuropathy. It often affects the hands and lower limbs and presents as a Stocking and Glove distribution. The important indicators of diabetic neuropathy are an increase in the duration of diabetes and HbA1c levels. Presently, it has been shown that the prevalence of DPN in India varies widely, ranging from 9.6 to 78percentage. 
According to WHO, the number of people with diabetic neuropathy has more than tripled globally since 1990, rising to 206 million cases in 2021. Damage to the nerves (diabetic neuropathy) affects up to 50% of people with diabetes. Although many different problems can occur as a result of diabetic neuropathy, common symptoms are tingling, pain, numbness, or weakness in the feet and hands. Combined with reduced blood flow, neuropathy in the feet increases the chance of foot ulcers and eventual limb amputation. 
Currently, it is treated by supplementation of vitamins (B6, B12, Folate), tricyclic agents (amitriptyline, imipramine), opioid analgesics (tramadol, oxylodone), anticonvulsants (phenytoin, carbamazepine) and gabapentin, but some of these drugs have been reported to develop side effects. 
Ibn Sina (Avicenna) in Al-Qanun fil Tibb has mentioned two specific complications of diabetes, which are gangrene and loss of sexual functions. They are closely related to vascular and neurological complications, as described in the modern pathology of diabetic neuropathy. Further, Razi (Rhazes) has mentioned in his book Al Hawi Fit Tib (Liber Continents) the concept of Khadar (neuropathy) and its occurrence in those tissues, which are somatosensory in nature. 
In Khadar (DN), the following changes occur, 1. Su-i-Mizaj Barid Madda (morbid cold temperament with substance) 2.Tafarruq-i-Ittesal (loss of continuity) – it is correlated with the discontinuity of nerve conduction caused by damage due to axonal degeneration, thickening of Schwann cell basal lamina, and accumulation of toxic substances in the nerve ending. 
As the literature review mentioned the properties of kalonji are Muhallil auram, Musakkin al-waja, and munaffith-i-balgham. The oil of kalonji is Muqawwi-i-bah wa Asab. In the classical book like Ghina Muna, Muhit-i-Azam use of kalonji in khadar(DN) is mentioned. An increasing amount of research links oxidative stress to diabetic neuropathy. Increased free-radical formation and a defect in antioxidant defenses which result in oxidative stress have been implicated in the pathogenesis of diabetic neuropathy. 
Kalonji is an annual herb possessing a wide range of medicinal uses apart from its commercial significance as a spice-yielding plant. Thymoquinone is the most active phytochemical compound in NS. Nigella sativa and thymoquinone have many proven therapeutic activities, and some potent activities are Antioxidants, immunomodulative, antiinflammatory, anti-diabetic, and Neuroprotective. Animal studies have been conducted on the effect of kalonji on Sciatic nerves in experimental Diabetic Neuropathy. With the help of literature research, in this study, an attempt is made to evaluate the efficacy of Kalonji in Diabetic Peripheral Neuropathy.
 
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