| CTRI Number |
CTRI/2020/10/028604 [Registered on: 23/10/2020] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study effect of
Yavani formulations on Menstrual Pain
|
|
Scientific Title of Study
|
Standard control clinical trial of various Kalpana of
Yavani on Udavartini Yonivyapad with special reference to primary dysmenorrhoea
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mauli Vaishnav |
| Designation |
Assistant Professor |
| Affiliation |
Parul University |
| Address |
Parul Institute of Ayurved and Research
Parul University
Limda
Tal Waghodia
Vadodara
A-101 Sardar Park
Gurukul Road
Visavadar
Dist Junagadh - 362130 Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9589788336 |
| Fax |
|
| Email |
maulivaishnav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rita Makim |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved, Parul University |
| Address |
Parul Institute of Ayurved,
Parul University
Limda
Tal Waghodia
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7990727524 |
| Fax |
|
| Email |
rita.makim@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mauli Vaishnav |
| Designation |
Assistant Professor |
| Affiliation |
Parul University |
| Address |
Parul Institute of Ayurved and Research
Parul University
Limda
Tal Waghodia
Vadodara
A-101 Sardar Park
Gurukul Road
Visavadar
Dist Junagadh - 362130 Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9589788336 |
| Fax |
|
| Email |
maulivaishnav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved and Research
Parul University
Vadodara |
|
|
Primary Sponsor
|
| Name |
Dr Mauli Vaishnav |
| Address |
Parul University
Limda
Tal Waghodia
Vadodara
Gujarat |
| Type of Sponsor |
Other [Self Sponsered] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mauli Vaishnav |
Parul Institute of Ayurved and Research |
OPD 5 Department of Prasuti Tantra and Streeroga
Vadodara
GUJARAT |
9589788336
maulivaishnav@gmail.com |
| Dr Mauli Vaisnav |
Pinnacle Biomedical Research Institute |
Animal Research division
Bhopal
MADHYA PRADESH |
9589788336
maulivaishnav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Animal Ethics Committee |
Approved |
| Institutional Ethics Committee for Human Trial |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mefenemic acid |
Group D - A single blind comparative clinical study where minimum of 50 patients diagnosed as Udavartini Yonivyapada will be selected and categorized in Group D -Mefenemic acid 250 mg three times per day for 3 days in control group for 3 cycles |
| Intervention |
Yavani Arka |
Yavani.
Botanical name : Trachyspermum ammi (Linn) Sprague.
Family : Umbelliferae.
A single blind comparative clinical study where minimum of 50 patients diagnosed as Udavartini Yonivyapada will be selected and categorized in
Group B - Yavani Arka -
These patients will be administered with Yavani Arka -10 ml 3 times per day orally with water.
The medication will be prescribed for 3 days during menstrual phase for 3 cycles.
|
| Intervention |
Yavani Arka bhavita Churna |
Yavani. Botanical name : Trachyspermum ammi (Linn) Sprague. Family : Umbelliferae. A single blind comparative clinical study where minimum of 50 patients diagnosed as Udavartini Yonivyapada will be selected and categorized in Grouo C -Yavani Arka bhavita churna- These patients will be administered with Yavani Arka bhavit Churna in capsule form-1 gm 3 times per day orally with water.
The medication will be prescribed for 3 days during menstrual phase for 3 cycles. |
| Intervention |
Yavani Churna
|
Yavani. Botanical name : Trachyspermum ammi (Linn) Sprague. Family : Umbelliferae. A single blind comparative clinical study where minimum of 50 patients diagnosed as Udavartini Yonivyapada will be selected and categorized in Group A – Yavani Churna- These patients will be administered with Yavani churna – 2 gm 3 times in a day orally with water. •Group B - Yavani Arka - These patients will be administered with Yavani Arka -10 ml 3 times per day orally with water. The medication will be prescribed for 3 days during menstrual phase for 3 cycles. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients complaining painful menstruation at least two consecutive cycles.
2. Patient having regular menstrual cycle.
|
|
| ExclusionCriteria |
| Details |
1. Acute infection,
2. Acyclic and excessive bleeding more than 4 pads/day or more than 5days.
3. Any pelvic pathology leading to dysmenorrhoea
4. Intra Uterine Contraceptive Device induced painful bleeding
5. All secondary causes leading to dysmenorrhoea
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Various kalpana of Yavani can be 70 % effective on Udavartini Yonivyapad WSR to Primary Dysmenorrhoea.
|
After completion of 3 cycle of menstruation and 5 cycles of menstruation
on the 4th day of menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Various kalpana of Yavani can provide 80 % beneficial effect on in pain during menstruation and provides beneficial effect on digestive system. |
on 3rd day of menstrual cycle
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="216" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/10/2020 |
| Date of Study Completion (India) |
30/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
2 publications done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dysmenorrhoea is one of the most common problem in female of reproductive age. Majority of cases of dysmenorrhoea fall in to the group of primary dysmenorrhea. A systematic review of studies in developing countries found that approximate 50 % of adult women, and about 75 % of adolescents, experienced pain with menstruation, with 5 - 20 % reporting severe dysmenorrhea or pain which prevents them from participating in their usual activities. Its prevalence is higher up to 5-15% more in intelligent, sensitive and stressful working class women.Primary dysmenorrhea can be correlated with Udavartini Yonivyapada characterized by pain during menstruation. Yavani (Trachyspermum ammi) is used for dysmenorrhoea in Indian folk lore practice since long ago. Acharya Bhavamishra has mentioned Yavani as ‘shoolahrit’ by which means the property of pain reduction.Along with this background the study will be conducted to evaluate and compare effect of Yavani in different dosage forms for the management of Udavartini Yonivyapad with special reference to Primary Dysmenorrhoea. MEthodology · Physicochemical analysis and safety profile will be evaluated prior to clinical study as per protocol. · A single blind comparative clinical study where minimum of 200 patients diagnosed as Udavartini Yonivyapada will be selected and categorized into 4 groups of 50 patients each. · Group A – Yavani Churna These patients will be administered with Yavani churna – 2 gm 3 times in a day orally with water. · Group B - Yavani Arka These patients will be administered with Yavani Arka -10 ml 3 times per day orally with water. Group C – Yavani Arka bhavita churna These patients will be administered with Yavani Arka bhavit Churna in capsule form-1 gm 3 times per day orally with water. · Group D – Control group These patients will be administered standard drug used for dysmenorrhea –Mefenamic acid 250 mg three times per day orally. - All medication will be prescribed for 3 days during menstrual phase.
- Follow up treatment will be given for 2 consecutive cycles during menstrual phase in all groups.
- Total study period 5 cycle = 3 months with intervention + 2 months without intervention observation
Assessment Criteria - VAS, Intensity of Pain, Duration of pain, Intramenstrual pain, Ammount of Blood loss and associate symptoms such as nausea, vomiting, anoraxia, headache, breast pain.
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