| 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
|
|
|
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
|
|
|
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.
|