| CTRI Number |
CTRI/2023/06/053385 [Registered on: 01/06/2023] Trial Registered Prospectively |
| Last Modified On: |
01/06/2023 |
| 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
|
Effect of Gulpha Marma Chikitsa and Yavani Churna in menstrual pain. |
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Scientific Title of Study
|
An Anatomico-clinical study on comparative effect of Gulpha Marma Chikitsa & Yavani Churna in Primary Dysmenorrhoea (Krichhartava) |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AMITA SHARMA |
| Designation |
PhD Scholar |
| Affiliation |
Faculty of Ayurveda IMS Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9131476980 |
| Fax |
|
| Email |
amitasharma1688@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Hari Hridaya Awasthi |
| Designation |
Professor |
| Affiliation |
Faculty of Ayurveda IMS Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415813194 |
| Fax |
|
| Email |
hhawasthi10@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR AMITA SHARMA |
| Designation |
PhD Scholar |
| Affiliation |
Faculty of Ayurveda IMS Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda Banaras Hindu University
UTTAR PRADESH
221005
India |
| Phone |
9131476980 |
| Fax |
|
| Email |
amitasharma1688@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Rachana Sharir Faculty of Ayurveda Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda IMS Banaras Hindu University |
| Address |
Department of Rachana Sharir Faculty of Ayurveda Banaras Hindu University |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amita Sharma |
Sir Sundarlal Hospital IMS BHU Varanasi |
OPD No 24 Department of Prasuti Tantra, Faculty of Ayurveda, Institute of medical Sciences, Sir Sundarlal Hospital Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH |
9131476980
amitasharma1688@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavani Churna, Reference: Charaka Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: Gulpha Marma Chikitsa | | 2 | Comparator Arm | Procedure | - | Gulpha Marma Therapy | (Procedure Reference: Sushruta Samhita Sharir Sthan, Procedure details: Gulpha Marma stimulation daily in the morning and evening as per technique for 3 months.
Gulpha Marma had to be stimulated for 15-18 times / min. with pressure bearable to the patients and every stimulus should be of 0.8 seconds. The process had to be repeated for 3 times per day. The pain threshold of the patient can be assessed by the facial expression of the patient and the pain generated during the Chikitsa can be alleviated by deep breathing or diversion of mind through conversation and re)
| | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
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Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients willing to participate in study.
2 Age group between 14 to 45 years.
3 Unmarried and married both patients attending the OPD with chief complain of Primary Dysmenorrhoea with scanty or average amount of menses along with associated symptoms without any organic pathology.
4 patients suffering more than two cycles.
|
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| ExclusionCriteria |
| Details |
1 Patients below 14 years and above 45 years.
2 Any abnormalities detected in investigation.
3 Coagulation disorders.
4 Patients suffering from chronic systemic disease like uncontrollable diabetes, uncontrollable hypertension, venereal disease, thyroid dysfunction or any disorders influencing general physical health and ultimately influencing menses.
5 Patients using IUCD and OCPs or injectables contaceptive and others.
6 Patients with any history of allergy or allergy from trial drugs.
7 Patients having Central nervous system disorders like epilepsy, meningitis, migraine or any other psychological disorders.
8 Patients having Respiratory disorders like bronchial asthma, T.B., pleural effusion, bronchitis etc.
9 Patients having any carcinoma.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduced Intensity and Duration of pain during menstruation |
Before intervention and
Every month after intervention for 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in associated sign and symptoms |
Before intervention and
Every month after intervention for 4 months |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2023 |
| 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="0"
Months="4"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amitasharma1688@gmail.com].
- For how long will this data be available start date provided 28-06-2024 and end date provided 28-09-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dysmenorrhoea
is the most common gynecological problem faced by female during adolescence
which causes significant discomfort and anxiety for the woman as well as
family. Primary Dysmenorrhoea is described as a pain that is of uterine origin
and directly linked to menstruation but with no visible pelvic pathology. The
incidence of Primary Dysmenorrhoea of sufficient magnitude with incapacitation
is about 15-20%. Primary Dysmenorrhoea is extremely common, especially among
adolescents, as many as 90% of adolescent females and above 50% of menstruating
women worldwide report suffering from it, with 10-20% of them describing their
hurt as sever and distressing.
In
the classics of Ayurveda, Dysmenorrhoea
is mentioned as symptom in many disorders like Vatala
Yonivyapada, Sannipatiki Yonivyapada, Paripluta Yonivyapada, Mahayoni,
Udavartini Yonivyapada, Antarmukhi Yonivyapada, Suchimukhi Yonivyapada.
The main cause of Primary Dysmenorrhoea (Krichhartava) is vitiation of Vatadosha (Apana and Vyana
Vata) which should be corrected
through the drugs of Vatashamaka and Vatahara properties. Krichhartava has strong relation with Vata Dosha because pain does not occur without vitiation of Apana Vata Dushti. As normal
menstruation is the attributed to the Apanavayu
Karma and hence painful menstruation is related with the vitiation of Vata especially the Apana Vayu, so painful menstruation is related is considered as Apana Vata Dushti. Plan of study
Total 90 patients of age group 14 to 45 years with
sign and symptoms of Primary Dysmenorrhoea (Krichhartava) without any other complications will be
registered from the OPD of Prasuti Tantra, S.S. Hospital (Ayurveda wing), IMS
BHU, Varanasi, by following proper assessment of inclusion and exclusion
criteria developed for the present research work and will be divided into three
groups as follows: Grouping
of Cases-All
the registered patients will be divided randomly in three trial groups A, B and
C by computerised method. Group
A- (30 cases): Group
A will be treated with Yavani churna
(2gm, in two divided dose) for duration of 90 days, 10 days prior to expected
date of menses for 3 consecutive cycle. Group
B-(30 cases): Group
B will be advised to do Gulpha Marma
stimulation daily in the morning and evening as per technique described below
for 3 months.
Group C-(30 cases): Controlled group C
will be treated with Placebo treatment (placebo capsule 1BD), nothing special
advice.
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