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CTRI Number  CTRI/2024/09/074273 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Management of Premenstrual syndrome 
Scientific Title of Study   Clinical Study of Premenstrual Syndrome and its Management with Unani Drug Revand chini 
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 Bisma 
Designation  PG Scholar  
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Ilmul Qabalat wa Amraz e Niswan, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan road, Karol Bagh, New Delhi 110005, India
House No.994, Gali Rajan Farash Khana Delhi 110006,India
New Delhi
DELHI
110005
India 
Phone  7838360380  
Fax    
Email  bisma2912@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shahana Ayub  
Designation  Assistant Professor and Supervisor 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Ilmul Qabalat wa Amraz e Niswan, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan road, Karol Bagh, New Delhi 110005, India
Quater no.30, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan road, Karol Bagh, New Delhi 110005, India
New Delhi
DELHI
110006
India 
Phone  7037881205  
Fax    
Email  shahanaayub86@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shahana Ayub  
Designation  Assistant Professor and Supervisor 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Ilmul Qabalat wa Amraz e Niswan, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan road, Karol Bagh, New Delhi 110005, India
Quater no.30, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan road, Karol Bagh, New Delhi 110005, India
New Delhi
DELHI
110006
India 
Phone  7037881205  
Fax    
Email  shahanaayub86@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol Bagh, New Delhi 110005, India  
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College and Hospital  
Address  Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol Bagh, New Delhi 110005, India 
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 Bisma  Ayurvedic and Unani Tibbia College and Hospital   Department of Ilmul Qabalat wa Amraz e Niswan, OPD no. 14, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Road, Karol Bagh, New Delhi, 110005, India
New Delhi
DELHI 
7838360380

bisma2912@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Ayurvedic and Unani Tibbia College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N943||Premenstrual tension syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Revand chini (Rheum emodi)  2 capsules of 500mg filled with fine powder of revand chini twice daily with water, from day 16 of the menstrual cycle to day 5 of the next for cycle for 3 months  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Patient aged within the range of 14 to 45 years, irrespective of marital status and parity.
2.Patient having regular spontaneous menstrual cycle of 21 to 35 days presenting with signs and symptoms of premenstrual syndrome for at least 3 menstrual cycles as per ACOG guidelines.
3.Patients who are able to understand and willing to report for follow ups and to sign the consent form.  
 
ExclusionCriteria 
Details 
1.Patients presenting with irregular menstrual cycle.
2.Patient on oral contraceptive pills and lactating women.
3.Patient having history of any unstable medical illness and seizure disorder.
4.Diagnosed case of personality disorder, depression or anxiety.
5.Patients with any systemic illness like renal or liver diseases.
6.Alcohol abuse or any other substance abusers.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety and efficacy of unani single drug in the management of Premenstrual syndrome   3 months or 3 menstrual cycles 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of unani drug in the improvement of quality of life of patient suffering from premenstrual syndrome.  3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/10/2024 
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="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  

The etiology of Premenstrual syndrome is complicated, and according to the hypothesized causes, various conventional therapeutic approaches have been recommended. As it is a chronic condition that needs prolong treatment for three to six months, therefore special attention should be paid to the side effects of pharmacological interventions.

Various drugs used in this condition are benzodiazepines, selective serotonin reuptake inhibitors and gonadotropin releasing hormone (GnRH) agonists. Despite a fair success rate of these medicines, each has a substantial adverse effect profile such as dysphoria, insomnia, muscle cramps, nausea, perspiration and tremor.

Therefore, the need of the hour is to switch towards complementary and alternative treatment for premenstrual syndrome. Which would be safe, less costly, more effective, easily available, and efficacious for the management of premenstrual syndrome.

In Unani classical texts, various plant products may be useful to treat symptoms of Premenstrual syndrome such as Qust Shireen, Sumbul-ul-Teeb, Asl-us-Soos, Tukhm-e-Sambhalu, Pudina, Bisfayej and Revand chini.

Several drugs have been subjected for clinical evaluation in Premenstrual syndrome such as Tukhm e Sambhalu, Balchar, Bisfayej and Pudina.

Revand Chini  contains a number of phenolic compounds including anthroquinones, stilbenes, tannin, polysaccharides and others which are proved to have various type of associated pharmacological activity. Ibn Sina in The Canon of Medicine  and Ibn Baitar in Compendium on Simple Medicaments and Foods given description for its usefulness in PMS .

According to a previous clinical study Revand chini has proved to be effective in primary dysmenorrhea but its effect on symptoms of follicular phase (Premenstrual phase) is not documented yet.

Therefore, in view of above, Revand chini (Rheum emodi)  is selected  to conduct clinical trial to evaluate  it’s efficacy  in the management of premenstrual syndrome.


 

 

 

 

 
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