| CTRI Number |
CTRI/2025/12/099550 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Early Seminal Discharge (Premature Ejaculation) with Unani Medicine Majoon-e-Mughalliz and Majoon-e-Piyaz. |
|
Scientific Title of Study
|
Comparative Clinical Validation study of Unani Pharmacopoeial formulation Majoon-e-Mughalliz vs Majoon-e-Piyaz in Surat-e-Inzal (Premature Ejaculation) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SI/PE/MM/MP/CLNVAL/CCRUM/23-24,Version No-01, 06.07.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Younis I Munshi |
| Designation |
Deputy Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West India
South West
South West
DELHI
110058
India |
| Phone |
09419086700 |
| Fax |
|
| Email |
younismunshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI India
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support:
1.National Research Institute of Unani Medicine for Skin Disorders, Opp. E.S.I., Hospital, A.G. Colony Road, Erragadda, Hyderabad–500838
2.Central Research Institute of Unani Medicine, Post & village, Basaha Kursi Road, Lucknow–226026
3.Regional Research Institute of Unani Medicine, Shah Jahan Manzil, Aligarh Muslim University, Aligarh–202001 |
| Monetary Support : Central Council for Research in Unani Medicine,Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Syed Gulnawaz Ahmad |
National Research Institute of Unani Medicine for Skin Disorders |
Research OPD Room Surat-e-Inzal (Premature Ejaculation),Opp. E.S.I., Hospital, A.G. Colony Road, Erragadda, Hyderabad – 500838
Hyderabad
TELANGANA |
9848716693
nawaz.ccrum@ccrum.res.in |
| Dr Misbahuddin Azhar |
Regional Research Institute of Unani Medicine |
Research OPD Room Surat-e-Inzal (Premature Ejaculation), Shah Jahan Manzil, Aligarh Muslim University.
UP-202001
Aligarh
UTTAR PRADESH |
8383096715
ccrum619@gmail.com |
| Dr Raghubanshi |
Regional Research Institute of Unani Medicine |
Research OPD Room Surat-e-Inzal (Premature Ejaculation), Post & village, BasahaKursi Road, Lucknow – 226026
Lucknow
UTTAR PRADESH |
9953014369
raghuji780078@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| National Research Institute of Unani Medicine for Skin Disorders , Hyderabad |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Aligarh |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F524||Premature ejaculation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon-e-Mughalliz |
5gm Twice daily taken orally with water after meals for 2 weeks. |
| Comparator Agent |
Majoon-e-piyaz
|
5gm Twice daily taken orally with water after meals for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1. Men with a PEDT score more than 8
2. Men with lifelong /Acquired PE meeting the evidence-based definition proposed by ISSM in 2013:
LPE:
i. IELT equal or less than 1 min from the first sexual experience
ii. Inability to delay ejaculation
iii. Related negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy.
APE:
i. A clinically significant reduction in IELT, often equal or less than 3 min
ii. Lacking the ability to delay ejaculation
iii. Related negative personal consequences as similar with that of LPE
|
|
| ExclusionCriteria |
| Details |
1. Patients with Erectile dysfunction
2. Major psychiatric disorders or cognitive impairments
3. Patients with history of intake of any drug causing sexual dysfunction and affecting psychological status
4. History of addiction (alcohol, drug abuse)
5. Male patients with confirmed hyperthyroidism and diabetes mellitus
6. Patients with chronic diseases requiring long term treatment |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the signs and symptoms of Surat-e-Inzal (Premature Ejaculation). Which will be assessed on the basis of PEDT (Premature Ejaculation Diagnostic Tool). |
At baseline and at the end of the study. i.e., 0 & 2nd weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical investigations for safety assessment i.e., Hemogram, ESR, LFT, KFT, Serum Uric Acid,Semen Analysis, Urine Examination: Routine & Microscopic |
At baseline and at the end of treatment. i.e., 0 & 2nd weeks
|
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
30/12/2025 |
| 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="2"
Months="0"
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
|
This study is designed as a multi-centric, Randomized, Parallel Group, Active Controlled trial in patients with Surat-e-inzal (Premature Ejaculation) . After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline and at the end of the treatment ( i.e., 0 & 2nd weeks). The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 2 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy ( i.e., 0 & 2nd weeks).
| S.No. | Ingredients | Botanical / Chemical name | Part used | Quantity | | 1. | Mastagi | Pistacia lentiscus Linn. | Exudates | 20 g | | 2. | Iklil ul Batam | Pistacia vera Linn. | | 30 g | | 3. | Kateera | Astragalus gummifer | Oleo Gum resin | 60 g | | 4. | Tabasheer | Bambusa arundinacea (Retz.) Roxb. Syn.: B. bambos Voss | Exudates | 60 g | | 5. | Heel khurd | Elettaria cardamomum (Linn.) Maton | Fruit | 60 g | | 6. | Darchini | Cinnamomum zeylanicum Blume | Stem bark | 60 g | | 7. | Samagh Arbi | Acacia arabica/nillotica Willd. | Oleo gum resin | 60 g | | 8. | Nishasta Gandum | Triticum aestivum Linn. | Flour | 60 g | | 9. | Salab Misri | Orchis latifolia Linn. | Root | 60 g | | 10. | Maghz Chilghoza | Piper attenuatum | Seed | 120 g | | 11. | Narjeel | Cocos nucifera Linn. | Fruit pulp | 200 g | | 12. | Maghz Badam | Prunus dulcis (Mill.) D.A. Webb | Seed | 240 g | | 13. | Asl or Qand Safaid | Honey / Sugar | | 2.5 Kg |
Composition of Majoon-e- Piyaaz | S.No. | Ingredients | Botanical / Chemical name | Part used | Quantity | | 1. | Tudri surkh | Cheiranthus cheiri L. | Seed | 35 g | | 2. | Tudri safaid | Matthiola incana R.Br. | Seed | 35 g | | 3. | Salab Misri | Orchis latifolia L. | Tuber | 35 g | | 4. | Behman Surkh | Salvia haematodes L. | Root | 35 g | | 5. | Behman Safaid | Centaurea behen L. | Root | 35 g | | 6. | Zanjabeel | Zingiber officinale Rosc. | Rhizome | 35 g | | 7. | Tukhm-e-Piyaz | Allium cepa L. | Seed | 35 g | | 8. | Tukhm-e-Turb | Raphanus sativus L. | Seed | 35 g | | 9. | Tukhm-e-Gandana | Allium ascalonicum L. | Seed | 35 g | | 10. | Tukhm-e-Shalgam | Brassica rapa L. | Seed | 35 g | | 11. | Talmakhana | Hygrophila auriculata (Schum.)Heine. | Seed | 35 g | | 12. | Musli safaid | Chlorophytum arundinaceum Baker. | Root | 35 g | | 13. | Musli siyah | Curculigo orchioides Gaertn. | Root | 35 g | | 14. | Aab-e-Piyaz Safaid | Allium cepa L. | Onion extract | 1.5 lit | | 15. | Qand Safaid | Sugar | Crystals | 1.5 kg |
|