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CTRI Number  CTRI/2025/02/080737 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 04/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Majoon e Najah capsules in menopausal symptoms.  
Scientific Title of Study   Assessing the efficacy of Majoon e Najah capsules (MNcf) in alleviating climacteric symptoms: A pilot 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  Karima Anees 
Designation  UG Student 
Affiliation  Ajmal Khan Tibbiya College AMU Aligarh  
Address  Dept. of Amraz e Niswan wa Qabalat, Ajmal Khan Tibbiya College AMU near Tasweer Mahal Aligarh,UP

Aligarh
UTTAR PRADESH
202002
India 
Phone  7983597068  
Fax    
Email  karimaanees125@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abiha Ahmad Khan  
Designation  Assistant Professor 
Affiliation  Ajmal Khan Tibbiya College AMU Aligarh 
Address  Department of Amraz-e-Niswan wa Qabalat Ajmal Khan Tibbiya College AMU Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9620551870  
Fax    
Email  abihaahmad89@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abiha Ahmad Khan  
Designation  Assistant Professor 
Affiliation  Ajmal Khan Tibbiya College AMU Aligarh 
Address  Department of Amraz-e-Niswan wa Qabalat Ajmal Khan Tibbiya College AMU Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9620551870  
Fax    
Email  abihaahmad89@gmail.com  
 
Source of Monetary or Material Support  
Aligarh Muslim University, AMU, Aligarh, U.P., India, 202002 
 
Primary Sponsor  
Name  Ajmal Khan Tibbiya College 
Address  Ajmal Khan Tibbiya College Aligarh Muslim University near Tasweer Mahal, Aligarh, UP, India, 202002 
Type of Sponsor  Government medical college 
 
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 Abiha Ahmad Khan  Ajmal Khan Tibbiya College and Hospital, AMU, Aligarh, U.P., 202002  Department of Niswan wa Qabalat, Aligarh Muslim University, Aligarh, U.P., India, 202002
Aligarh
UTTAR PRADESH 		 9620551870

abihaahmad89@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe, Ajmal Khan Tibbiya College, AMU, Aligarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N951||Menopausal and female climactericstates,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Majoon e Najah Capsules (MNcf)  Capsule MNcf 500mg x 2 thrice a day (3gm) x 1 month 
Comparator Agent  NOT APPLICABLE   NOT APPLICABLE  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  The patients for the study will be selected from the following criteria:
1. Females in the menopause age (45-55 years).
2. Subjects presenting with menopause related symptoms.
3. Subjects willing to participate and sign the informed consent form. 
 
ExclusionCriteria 
Details  Exclusion criteria:
Female patients with treatment history of Diabetes mellitus, Malignancy etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in Green Climacteric Scale.  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Vasomotor symptoms (hot flushes, sweating at night)  1 month 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   26/02/2025 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Majoon e Najah (MN) is a traditional semisolid sweetened polyherbal Unani formulation. The main indication is for mMelancholic (Saudawi) diseases because of its potent action of Muqawwi-e-Asab (Nervine Tonic) and Tafreeh-wa-Taqwiyat (Mood elevation and potentiating).

In general, females in the perimenopausal age suffer from lifestyle disorders and are either prediabetic or diabetic. Majoon e Najah which is a sugar based unani formulation cannot be prescribed to diabetic menopausal females as it can lead to spikes in blood glucose levels. A capsule preparation usually does not contain sugars and is a safer option. 

Keeping this observation in view, the crude drugs as ingredients in Majoon-e-Najah excluding the sugar is being modified into capsule form for use in females presenting with menopause related symptoms. 
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