| 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
|
|
|
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
|
|
|
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. |