| CTRI Number |
CTRI/2026/02/103937 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study of Nerve Pain and Numbness in People with Diabetes, Comparing Habb-e-Azaraqi With Standard Treatment |
|
Scientific Title of Study
|
A Clinical Study on Diabetic Peripheral Neuropathy and Comparative Evaluation of Habb-e-Azaraqi With Standard Control in its Management |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tabi Idris Siddiqui |
| Designation |
MD Scholar (UNANI) |
| Affiliation |
Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh |
| Address |
Department of Moalajat, Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7599300400 |
| Fax |
|
| Email |
tabiiidris@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mursaleen Naseer |
| Designation |
Assistant Professor |
| Affiliation |
Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh |
| Address |
Department of Moalajat, Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412562724 |
| Fax |
|
| Email |
mursaleennaseer1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tabi Idris Siddiqui |
| Designation |
MD Scholar (UNANI) |
| Affiliation |
Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh |
| Address |
Department of Moalajat, Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7599300400 |
| Fax |
|
| Email |
tabiiidris@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalajat, Ajmal Khan Tibbiya College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India (PIN CODE: 202002) |
|
|
Primary Sponsor
|
| Name |
Department of Moalajat, Ajmal Khan Tibbiya College, Aligarh Muslim University, Aligarh |
| Address |
Department of Moalajat, Ajmal Khan Tibbiya College, Aligarh Muslim University, Aligarh 202002 |
| 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 Tabi Idris Siddiqui |
Ajmal Khan Tibbiya College Hospital |
Department of Moalajat, Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh 202002
Aligarh
UTTAR PRADESH |
7599300400
tabiiidris@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Habb-e-Azaraqi |
The ingredients of formulation are as follows:
Jawitri (Myristica fragrans) 29mg
Jaifal (Myristica fragnans) 29mg
Darchini (Cinamomoum zeylanicum) 29mg
Smagh e Arabi (Acacia arabica) 34mg
Ood Saleeb (Orchis officinalis) 29mg
Qaranphal Guldar (Syzygium aromaticum) 29mg
Kuchla Mudabbar (Strychnos nuxvomica) 58mg
Ajwain Desi (Tachyspermum ammi) 11.6mg
Ararot q.s.
1 tablet will be given after meal twice daily orally for 2 months. |
| Comparator Agent |
Methylcobalamine 750mcg + Pregabalin 75mg |
1 Tablet will be given Once Daily Orally for 2 Months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients of diabetic peripheral neuropathy with Type 2 diabetes mellitus through TCNS.
Patients between the age of 30 to 60 years of age.
Patients of either sex.
Controlled case of Type 2 diabetes mellitus either by drug or life style modification. Fasting
blood sugar less than or equal to 150 or HbA1c less than or equal to 8.
Patients willing to participate in the study and follow the instructions.
Washout period of 20 days for patient who were already taking any drug for neuropathy. |
|
| ExclusionCriteria |
| Details |
Patients below 30 years and above 60 years of age.
Uncontrolled case of diabetes mellitus. HbA1c greater than 8.
Physiological status: pregnancy and lactation
Pathological status: cardiovascular diseases, renal diseases, hepatic diseases, thyroid dysfunction.
Complications of diabetes mellitus other than diabetic peripheral neuropathy.
Causes of neuropathy other than diabetes.
Patient having ischaemic or neuropathic ulcer.
Patients taking neurotoxic drugs.
Clinically suspected cases of compressive neuropathy.
Any comorbid condition.
Alcoholics.
Severe loss of vibration sensation. VPT value greater than 25 volts.
Patients who refuse to give written consent for the study and who fail to follow up. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement In Vibration
Perception Threshold Value
Grade 0 No Loss Of Vibration
Perception-Complete
Improvement
Grade 1 Borderline Loss Of
Vibration Perception-Slight
Improvement.
Grade 2 Mild Loss Of
Vibration Perception-Partial
Improvement.
Grade 3 Moderate Loss
Vibration Perception-No
Improvement.
Improvement In The Score For
10 Gram Monofilament. |
Assessment Of Vibration Perception
Threshold Through Drp At Initiation Of
Study (0 Day) And At The End Of Study (60
Days).
10 Miligram Monofilament Test At
Initiation Of The Study (0 Day) And At The
End Of Study (60 Days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement In The Subjective Parameters:
Loss Of Light Touch And Temperature
Sensation
Numbness And Parasthesia Or Both In Feet
And Hands
Pain Symptoms Icluding Burning Allodynia
(Contact Pain). |
Assessment On 0, 15, 30, 45
And 60 Days. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Diabetes mellitus and its complications are a major and growing global health problem, and diabetic neuropathy is among the most significant and troublesome microvascular complications, causing considerable morbidity and burden on quality of life. Diabetic peripheral neuropathy is the most common form and can progress to serious outcomes such as foot ulceration, gangrene, and amputation; current therapies may reduce symptoms but do not prevent disease progression, creating a need for safe and effective treatment options. In this context, the Unani formulation Habb-e-Azaraqi (used for wajaulasab) is proposed for evaluation on scientific parameters in diabetic peripheral neuropathy. This study is planned as an open randomized standard controlled clinical trial with 60 patients (30 test, 30 control), recruited from Moalajat/Modern Medicine OPD/IPD and referrals at Ajmal Khan Tibbiya College and Hospital (AMU, Aligarh). The test group will receive Habb-e-Azaraqi (1 tablet twice daily after meals) for 60 days, while the control group will receive Methylcobalamin 750 mcg + Pregabalin 75 mg (1 tablet once daily) for 60 days. Efficacy will be assessed using subjective symptoms and objective measures including vibration perception threshold (VPT), 10 g monofilament test, and Toronto Clinical Neuropathy Score, with follow-ups on days 0, 15, 30, 45, and 60 (key objective measures at baseline and day 60). |