| CTRI Number |
CTRI/2024/11/077286 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effects of Unani Polyherbal Formulation,
in patients with Primary Dysmenorrhoea |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE MANAGEMENT OF PRIMARY
DYSMENORRHOEA (USRE TAMS IBTIDAEE) WITH A UNANI
POLYHERBAL FORMULATION- AN OPEN LABEL SINGLE ARM
TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohd Taalib Mustafa |
| Designation |
Pg Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College Hospital |
| Address |
Deptt of qabalat wa amraze niswan A & U Tibbia College and Hospital Ajmal Khan road Karol bagh
New Delhi
DELHI
110005
India |
| Phone |
9315060872 |
| Fax |
|
| Email |
talib4817@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aysha Raza |
| Designation |
Associate professor |
| Affiliation |
Ayurvedic and Unani Tibbia College Hospital |
| Address |
Department of Qabalat wa amraze niswan Ayurvedic and Unani Tibbia College Hospital
Central
DELHI
110005
India |
| Phone |
9354925031 |
| Fax |
|
| Email |
draysharaza11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aysha Raza |
| Designation |
Associate professor |
| Affiliation |
Ayurvedic and Unani Tibbia College Hospital |
| Address |
Department of Qabalat wa amraze niswan Ayurvedic and Unani Tibbia College Hospital
Central
DELHI
110005
India |
| Phone |
9354925031 |
| Fax |
|
| Email |
draysharaza11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital , Ajmal khan road Karol Bagh delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College Hospital |
| Address |
ajmal khan road karol bagh delhi 110005 |
| 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 Mohd Taalib Mustafa |
Ayurvedic and Unani Tibbia College and Hospital |
OPD NO 14 , Department of Qabalat wa Amraze Niswan,Ayurvedic and Unani Tibbia College and Hospital,Ajmal khan road karol Bagh Delhi 110005
Central
DELHI |
9315060872
taalib4817@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Post Graduate Research Protocols (Unani) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Mur Makki (Commiphora myrrh)
2. Abhal (Juniperus communis)
3. Suddab (Ruta graveolens)
4. Majeeth (Rubia cordifolia) |
An Aqueous extract powder filled capsule of 625 mg of the following drugs will be given as two capsules twice a day for 4 days prior to expected start of menses and 3 days during menses for 3 consecutive cycles.
1. Mur Makki (Commiphora myrrh) 385mg/capsule- which is Har Yabis2 (Hot and dry) in Mizaj and
possess the properties of Mudir e Haiz (emmenagogue) Dafe tashannujh Mudir e Baul
(diuretic)
2. Abhal (Juniperus communis) which is Har Yabis 2 (Hot and dry) 40mg/capsule- and possess the
properties of Mudir e Haiz (emmenagogue) Mufattih e sudad (deobstrulent) Mudir e Baul
(diuretic).
3. Suddab (Ruta graveolens) 100mg/capsule-which is Har Yabis 2 (Hot and dry) and possess the properties of
Mudir e Haiz (emmenagogue) Mudir e Baul (diuretic) Dafeh tashannauj.
4. Majeeth (Rubia cordifolia) 100mg/capsule- which is Har Yabis 2 (Hot and dry) and possess the properties of
Mufattih e sudad (deobstrulent) Mudir e Haiz (emmenagogue). |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
Patients in age group of 14-28 years of age, Patient with VAS Score of 4 to 10, Unmarried, Patient able to participate in the study and ready to follow the instructions and signed the informed consent |
|
| ExclusionCriteria |
| Details |
Patient with Secondary Dysmenorrhoea, Patient having any organic Pelvic pathology (Pelvic inflammatory Disease , Uterine
Fibroid, Endometriosis, Adenomyosis , Adnexal Masses , Endometrial Polyp), Patient with severe diseases (DM, IHD, HTN TB,Thyroid diseases and Renal diseases), Married, Age more than 28 years, Patient with H/O malignancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS) :
VAS for pain intensity of Dysmenorrhoea
0-No pain ; 1-3 - Mild pain ; 4-6 - Moderate Pain ; 7-10 - Severe Pain. |
baseline , after 1st menstrual period, after 2nd menstrual period, after 3rd menstrual period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
04/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
A single arm study will be carried out on Usre tams Ibtidaee (primary dysmenorrhoea) with unani polyherbal formulation. Usre tams Ibtidaee (primary dysmenorrhoea) common gynecological complaint that can effect as much as 50% of the women and 10% of these women have a severe impact which makes it a major cause of absenteeism from work leading to decreased efficiency and quality of life.Primary Dysmenorrhoea is high in girls in adolescence age there are estimations suggesting that around 60% of girls of 12-17 years of age group experience some degree of menstrual cramps The prevalence is highest during 20-24 years of age.In classical Unani text Dysmenorrhoea is known as Usr-e-tams or Waja-e-rehem.Renouned unani physician A’zam Khan mentions the causes of dard-e-rahim as su’mizaj, riyah-e-ghaleez, rutubat alghaleeza (tenuous morbid matter), quruh al-rahim, buthur al-rahim, saratan al-rahim, inqilab al-rahim, shuqaq al-rahim (uterine rupture), mailan al-rahim (displacement of uterus), excessive intercourse, and postpartum period uterine pain or pain occurring during menstruation Symptoms include The cramping pain are colicky spasm of pain occurring few hours before or after the onset of menstruation peaking within first few days as menstrual flow increases felt at lower abdomen that may radiate to lower part of the thigh.In conventional medicine therapeutic options for Primary Dysmenorrhoea include Non steroidal anti-inflammatory drugs(NSAIDs) which act as prostaglandin inhibitors , Opioid Analgesics and Oral contraceptive Pills (OCPs) which act by inhibiting ovulation are the most reliable and effective treatment. NSAIDs are effective for some women but not for all as these have various adverse effects and upto 20%-25% failure rate to reduce Primary Dysmenorrhoea The treatment of Usr-e-tams in Unani system of medicine indicates the use of Mudir e Haiz , mufattih e sudad , and Dafe Tashannuj properties. Unani formulation comprising of 625mg Capsule of powder of aqueous extract of Mur Makki(325mg), Abhal(25mg), Barg Suddab(75mg), Majeeth(75mg) taken as 2 capsules twice a day with plain water are selected as research drug. Research drug will be given 3 Days Prior to menses and 4 days during menses for 3 consecutive cycles.During the trial , efficacy of treatment will be assessed by observing changes in rating score of subjective and objective parameters. At every follow up, the subjects will be enquired about the improvement or deterioration in symptoms and recorded. After the completion Pre and Post treatment values statistically analyzed.Objective Parameters includes Visual Analogue Scale (VAS) : VAS for pain intensity of Dysmenorrhoea , at baseline and at each follow up. 0-No pain ; 1-3 - Mild pain ; 4-6 - Moderate Pain ; 7-10 - Severe Pain. and Verbal Multidimensional Scoring System (VMS)-The severity of Dysmenorrhoea will be assessed by a VMS. Subjective Parameters includes Associated Symptoms such as Nausea , Vomiting , headache , fatigue will be assessed by VAS. Vertigo symptom scale was used to record Dizziness as 0- never, 1-Few times, 2- Several times, 3-Quite often, 4-Very Often During the trial ,safety of treatment will be assessed by LFT ,KFT Will be carried out at baseline and visit 3 patient that will be included using following criteria i.e Patients in age group of 14-28 years of age.,Patient with VAS Score of 4 to 10.Unmarried.Patient able to participate in the study and ready to follow the instructions and signed the informed consent..Patient will be WITHDRAWL if they Failure to follow the Protocol and investigator instruction. or in Any serious or adverse reaction or event
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