FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065912 [Registered on: 18/04/2024] Trial Registered Prospectively
Last Modified On: 17/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [MARMA CHIKITSA]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Clinical Study: Marma Chikitsa And Yoga - Pranayama For Menopausal Symptoms Management. 
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Efficacy Of Marma Chikitsa And Yoga - Pranayama In The Management Of Menopausal Symptoms (Rajonivritti janya Vikara). 
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 Yatri K Thakker 
Designation  PG Scholar 
Affiliation  Parul Institute Of Ayurved 
Address  Room No. 309, Department of Prasuti Tantra Evum Stri Roga, Parul Institute Of Ayurved, Parul University,Limda, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8140889698  
Fax    
Email  yatrithakker@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vrushalee Dodke 
Designation  Professor 
Affiliation  Parul Institute Of Ayurved 
Address  Room No. 309, Department of Prasuti Tantra Evum Stri Roga, Parul Institute Of Ayurved, Parul University,Limda, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9823088621  
Fax    
Email  vrushaleedodke@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vrushalee Dodke 
Designation  Professor 
Affiliation  Parul Institute Of Ayurved 
Address  Room No. 309, Department of Prasuti Tantra Evum Stri Roga, Parul Institute Of Ayurved, Parul University,Limda, Vadodara


GUJARAT
391760
India 
Phone  9823088621  
Fax    
Email  vrushaleedodke@gmail.com  
 
Source of Monetary or Material Support  
Parul Ayurved Hospital, Parul University, Vadodara, Gujarat 391760 
 
Primary Sponsor  
Name  Parul Institute Of Ayurved 
Address  Room No. 309, Department of Prasuti Tantra Evum Stri Roga, Parul Institute Of Ayurved, Parul University,Limda, Vadodara 
Type of Sponsor  Research institution and hospital 
 
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 Yatri K Thakker  Parul Ayurved Hospital  Opd No 104, Stri Roga Evum Prasuti Tantra Opd, Parul Ayurved Hospital,Parul University PO Limda TAL Waghodia Vadodara 391760
Vadodara
GUJARAT 
8140889698

yatrithakker@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Parul Institute of Ayurved, Parul University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: RAJONASAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: TY - JOUR AU - Negi, Vineeta AU - Susheela, Parvat AU - Anju, Vyas AU - Pandoh, Jaral PY - 2018/08/04 SP - 258 EP - 271 T1 - Marma and Marma Therapy: A Review VL - 7 DO - 10.20959/wjpr201815-12973 JO - World Journal of Pharmaceutical Research ER -, Procedure details: POORVA KARMA 1. Patient will be asked to empty the bladder. 2. Patient will be asked to lie down comfortably for Marma stimulation. 3. Hands will be sanitized. 4. Patient’s privacy will be maintained during therapy. PRADHAAN KARMA 1. Marma points will be located and stimulated one by one. 2. Marma point is touched either with the inter-phalangeal joint or side tip or pulp of thumb or fingers. 3. Pressure to be applied: ¼ Maathirai. 4. Each Marma point will be pressed for 15-18 times)
2Comparator ArmProcedure-vyAyAmaH, व्यायामः (Procedure Reference: 1. Joshi S, Khandwe R, Bapat D, Deshmukh U. Effect of yoga on menopausal symptoms. Menopause International. 2011;17(3):78-81. doi:10.1258/mi.2011.011020, Procedure details: 1. A special protocol of Yoga-Pranayama will be followed. 2. Patient will be instructed regarding Yoga-Pranayama to be done by herself. 3. It should be done in morning or evening hours, with empty stomach (at least having gap of 3-4 hours after meal) and in peaceful environment. 4. Clean, light colored and loose clothing should be done. 5. Proper and clean Yoga mat should be there. 6. Sitting in Padmasana (sitting with both legs crossed above each other and hands relaxing on the knees) and )
 
Inclusion Criteria  
Age From  46.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Willing and ready to give consent
2. Having symptoms as per menopause rating scale (MRS).
3. Menopause rating scale (MRS) score more than 11 
 
ExclusionCriteria 
Details  1. Women with Known Case of hypothyroidism, heart disease, diabetes mellitus.
2. Established case of any mental health disorders undergoing any treatment.
3. Known case of carcinoma (any type of malignancy).
4. Patient suffering from Menorrhagia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Menopause Rating Scale  15th day, 45th day, 75th day 
 
Secondary Outcome  
Outcome  TimePoints 
overall well being of female  15th day, 45th day, 75th day 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 3 
Date of First Enrollment (India)   06/05/2024 
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)  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  

   INTRODUCTION:

Definition: Menopause means permanent cessation of menstruation at the end of reproductive life due to loss of ovarian follicular activity. It is the point of time when last and final menstruation occurs.

•       The clinical diagnosis is confirmed following stoppage of menstruation (amenorrhea) for twelve consecutive months without any other pathology.

•       It is a natural biological process, which is experienced individually by every woman. Some women notice little difference in their body or moods, while other find the changes extremely bothersome and disruptive.

•        The age of menopause ranges between 45–55 years, average being 50 years.

•       Climacteric is the period of time during which a woman passes from the reproductive to the non-reproductive stage. This phase covers 5–10 years on either side of menopause. 

•       Perimenopause: The term perimenopause should include the period immediately prior to the menopause (when the endocrinological, biological, and clinical features of approaching menopause commence) and the first year after menopause.

•        Post menopause is the phase of life that comes after the menopause.

MENOPAUSAL SYMPTOMS 

(A)  ACUTE / SUB ACUTE ONSET SYMPTOMS:

1) Vasomotor (Hot Flush, Night Sweat)

2) Genital and Urinary (Dyspareunia, Dysuria etc.)

3)Vagina (Dryness, Pruritus & Leucorrhea)

4)Sexual Dysfunction

5) Psychological (Anxiety, Irritability, Depression)

6) Skin and Hair (“Crow feet”)

(B)  DELAYED ONSET SYMPTOMS:

1) Cardiovascular

2) Cerebro-vascular

3) Osteoporosis and fractures

4) Dementia and Alzheimer.

RAJO NIVRITTI

·         à¤¤à¤¦à¥à¤µà¤°à¥à¤·à¤¾à¤¦à¥ à¤¦à¥à¤µà¤¾à¤¦à¤¶à¤¾à¤¦à¥ à¤•ाले à¤µà¤°à¥à¤¤à¥à¤¤à¥à¤®à¤¾à¤¨à¤®à¤¸à¥ƒà¤•् à¤ªà¥à¤¨à¤ƒ à¥¤ à¤œà¤°à¤¾à¤ªà¤•्व  à¤¶à¤°à¥€à¤°à¤¾à¤£à¤¾à¤‚ à¤¯à¤¾à¤¤à¤¿ à¤ªà¤¨à¥à¤šà¤¾à¤¶à¤¤à¤ƒ à¤•्षयम् à¥¤ à¥¤  (Su.Sha.3/9)

•       As Acharya Sushruta has mentioned menopause related with Jarapakva Avastha of the body. Age for Rajo Nivritti is 50 years. Acharya Sushruta mentioned Jara as Swabhavik Vyadhi.

•       Though Rajonivritti is physiological phenomenon but due to the fast life, rapid migration, stress, strain, tension, hurry-worry, repeatedly leads to Dhatu Kshaya Avastha which stimulates the aging process. Due to this aging process and incapability to bear the condition and it becomes a state of pathology 

MARMA CHIKITSA 

·         Marma therapy focuses on energizing the body to relieve occupational illness and stress related diseases.

·         Hence the complete knowledge of the basic principles of Marma and its clinical application can play an important role in treatment modalities.

·         First & foremost literature of Marma is found in Brihattrayee described in the sixth chapter of Sushruta Samhita Sharir Sthana.

·         This science was used both in warfare and surgery.

·          From common ailments to serious neuromuscular diseases, all can be treated by Marma therapy.

·         Common ailments like headache, body ache, faulty spinal alignment, pain in the joints can be rejuvenated through Marma Chikitsa.

·         Marma points, considered “doorways” or “entry points” into our body’s inner pathways, when gently pressed on the skin can stimulate a chain of positive events.

·         Relieving pain, blockage or swelling at Marma sites is an important therapeutic aid and one of the first stages of many Ayurvedic treatments.

·         Ayurveda treats Marma with pressure, heat, needles, massage oils, herbs or aromatic oils, providing many tools for working with our internal energies through them.

·         Vaidya can use Marma points to monitor and treat the level of Tridosha specifically Vata in patient’s bodies and minds.

·         They can get benefit from Marma therapy that aims at reducing Vata from its various places of accumulation in the large intestine, bones, joints and nervous system.

·         Marma therapy can be used for pain relief, reducing stiffness, stopping tremors, relieving constipation, calming down anxiety, relieving stress, promoting sleep and other Vata-reducing actions.

MODE OF ACTION OF MARMA THERAPY

·         The mode of action of Marma Therapy may be understood through various ancient and modern concepts as follows.

·         Marmas are connected to the Nadis (subtle nervous system) and Chakras (subtle energy centers) of the subtle body.

·          The Chakras can be considered to correspond to seven main Marmas or Pranic centers, which provide energy to all other Marmas.

·         Through stimulation of Marma points, the flow of Prana through the Chakras can be stimulated, thus activating them, and resulting in the awakening of subtle dormant areas in the brain, that leads to the experiencing of higher realms of consciousness, which are normally inaccessible; this, in turn, can lead to better control over the mind-body network including the autonomic nervous system and various organs, resulting in an overall healing effect.

·         As Marmas are the seats of Prana, the vital life force that governs the physical and subtle processes of the body, therefore, through the stimulation of Marmas, the flow of Prana in different body parts can be modulated in such a way that it can be used to remove blockages, and decrease or enhance the physical and subtle energy currents within the body, resulting in the corresponding healing effect.

·          Since Prana is connected to Vata Dosha, hence Marma Therapy can be especially useful in treating the Vata disorders.

YOGA 

Yoga is a commonly known generic term for physical, mental, and spiritual disciplines which originated in ancient India. The 3 main focuses of Yoga include: Exercise, Breathing and Meditation. The system of Yoga believes that “Prana”, or healing “life energy” is absorbed into the body through the breath, and can treat a wide variety of illnesses and complaints. Yoga helps to improve flexibility, strength and balance. Yoga is aimed to unite the mind, the body, and the spirit. It helps the person

to become more aware of the body’s posture, alignment and patterns of movement. It makes the body more flexible and helps to relax even in the midst of a stress-stricken environment. Previous studies have shown the benefits of Yoga therapy in treating the climacteric symptoms of menopause.

Regular practice of Yoga promotes strength, endurance, flexibility and facilitates characteristics of friendliness, compassion, and greater self-control, while cultivating a sense of calmness and wellbeing. Yoga offers as effective method of managing and reducing stress, anxiety and depression, and numerous studies demonstrated the efficacy of Yoga on mood-related disorders. Yoga, a form of mind-body fitness that involves a combination of muscular activity and an internally directed mindful focus on awareness of the self, the breath, and energy. Currently, treatment for anxiety and depression involves mostly psychological and interventions; however, mind-body interventions are becoming an increasingly popular as a mean to reduce stress. 

Specific Yoga poses can induce the relaxation response in the body. Calming and restorative poses along with controlled breathing activate the parasympathetic nervous system, bringing the mind and body to a calm and relaxed state.

A study by Streeter et al  suggests that the practice of yoga may reduce the depressive symptoms of perimenopause by increasing GABA levels in the brain. This study examined the GABA levels by

measuring the GABA-to-creatinine ratio in the brain and showed a 27% increase in GABA levels in the yoga group after a 60-minute yoga session. This may explain the decrease in the psychological symptoms in menopausal women following yoga.

SURYA NAMASKAR

 It is also known as Sun Salutation. It is a common sequence of AsanasAsana means maintaining a body posture for a particular time. The Asanas included in Surya Namaskar are PranamasanaHasta Uttanasana, Hastapaadasana, Aekpaadprasarnaasana, Adho Mukha Svanasana, Ashtanga Namaskara, Bhujangasana, Adho Mukha Svanasana, Ashwa Sanchalanasana, Uttanasana, Hasta Uttanasana, Pranamasana . Various studies have evaluated the beneficial effects of Surya Namaskar on physiological functions.

PRANAYAMA

Pranayama is the conscious expansion of inhalation and exhalation in a specific manner. It is a scientific process of internal purification, draws the mind inwards and connects to deeper levels of consciousness. Pranayama refreshes and energizes the brain, calms the mind, removes stress, negativity and makes all the systems function well.


  NEED OF THE STUDY:

Ø  CLINICAL IMPORTANCE:

•       Due to increased life expectancy, especially in affluent society, about one-third of life span will be spent during the period of estrogen deprivation stage with long-term symptomatic and metabolic complications.

•         Prevalence of menopausal symptoms:  It was found to be 87.7%. Majority of the study subjects had anxiety (80%), followed by physical and mental exhaustion (71.5%), sleep problem (61.2%), irritability (60.7%), Joint and muscular discomfort (56%) and heart problems (54%). The most classical symptom of menopause i.e., hot flushes were reported in 36.7%. The mean age of menopause was 47.53 standard deviation 4.5 years.  Statistically significant difference was seen for the mean score of few symptoms i.e., hot flushes, sweating (P < 0.003) and joint and muscular discomfort (P < 0.014) between post and peri-menopausal groups. The QOL was impaired in 70.2% of study subjects. The psychological symptoms attributed 70.8% to the poor QOL.

•         HRT (Hormone replacement Therapy) and Symptomatic treatment are only options for Menopausal Syndrome in Morden Science.

•       Potential health risks of HRT: Endometrial cancer, Endometrial hyperplasia, Breast cancer, Gall bladder disease, Thrombophlebitis.

•       Side effect of HRT:

- Estrogen related: Vaginal bleeding, Increased cervical mucus, Nausea, Vomiting, Fluid retention, Weight gain

-Progesterone related: Symptoms like PMS, Anxiety, Irritability, Depression, Sleep disturbances.

-Others: Itching, Headache, Cardiac Problems, Loss of hair etc.

AIM:  To evaluate the efficacy of Marma Chikitsa in the management of Menopausal symptoms.

OBJECTIVES

1. To adopt and implement standard operating procedure of Marma Chikitsa in the management of Menopausal symptoms. 

2. To study and adopt usefulness of Marma Chikitsa in the management of Menopausal symptoms. 

3. To compare the efficacy of Marma Chikitsa and Yoga-Pranayama in the management of Menopausal symptoms.

HYPOTHESIS:

Null Hypothesis: (H0) – There is no effect of Marma Chikitsa in the management of Menopausal symptoms.

Alternative Hypothesis: (H1) – Marma Chikitsa is as effective as Yoga-Pranayama in the management of Menopausal symptoms.

(H2– Marma Chikitsa is more effective than Yoga-Pranayama in the management of Menopausal symptoms.

(H3– Marma Chikitsa is less effective than Yoga-Pranayama in the management of Menopausal symptoms.

Diagnostic criteria:

  Objective parameters â€“

Serum FSH: > 40 mlU/mL (Before Treatment)

Serum Oestradiol: < 20 pg/mL (Before Treatment)

Subjective parameters – MRS Scale (Menopause Rating Scale)

 Duration Of Treatment: 2 months (total 2 Courses)

Group A: 1 Course of 15 continuous days in a month for consecutive 2 months.

Group B: 1 Course of 16 days in a month for consecutive 2 months.

(4 continuous days in a week – total 16 days in a month)

Follow up period:

Follow up after 30 days of last day of 2nd Course.

Inclusion criteria:

1.       Willing and ready to give consent.

2.       Female Age group between 46-55 years.

3.       Having symptoms as per menopause rating scale (MRS).

4.       Menopause rating scale (MRS) score  more than 11.  

(g)    Exclusion criteria:

1.       Women with Known Case of hypothyroidism, heart disease, diabetes mellitus.

2.       Established case of any mental health disorders undergoing any treatment.

3.       Known case of carcinoma (any type of malignancy).

4.       Patient suffering from Menorrhagia. 

(g)    Study Duration: 3 Months.

(h)   Assessment ParametersMRS Scale (Menopause Rating Scale) (International versions of the Menopause Rating Scale).

        Gradation of severity of Menopause Syndrome will be calculated from MRS expressed as under:  

SCORE

a)        00 - 05                   None/Mild/Doubtful (Grade 0)

b)       06 - 10                   Moderate (Grade 1)

c)        11 - 15                  Severe (Grade 2)

d)       16 - 20                  Extremely severe (Grade 3)

 Percentage of relief will be graded as: -

a)       00 - 20 %               No relief

b)      21 – 40 %               Mild

c)       41 – 60 %               Moderate

d)      61 - 80 %                Good

e)       81 - 100 %              Completely cured

(g)    Laboratory Investigations:

S.FSH (Before treatment)

Oestradiol (Before treatment)

S. T3, T4, TSH (Before treatment

INTERVENTION:

Women having symptoms of Menopause and are fulfilling inclusion criteria will be recruited and will be randomly allocated into two groups.

Group A:

 Marma therapy will be administered by pressure method.

 Marma therapy will be administered for 15 days continuously in a month for consecutive 2 months.

 Rescue medicine: Murivenna Oil (Local Application).

Group B:

A special protocol of Yoga-Pranayama will be followed.

·        Patient will be instructed regarding Yoga-Pranayama to be done by herself.

      MARMA TO BE STIMULATED DURING THIS STUDY:

       1ADHIPATI 

       2. SIMANTA

       3. STHAPANI

      4. SHRINGATAKA

      5. MANIBANDHA

      6. TALAHRIDAYA

      7. NABHI

      8. KATIKATARUNA

      9. KUKUNDARA

      10. INDRABATSI

       YOGA-PRANAYAMA TO BE PERFORMED DURING THE STUDY:

      1. CHANTING OMKARA

      2. ANULOMAVILOMA PRANAYAMA

      3. BHRAMARI PRANAYAMA

      4. SURYANAMASKARA

      5. SHAVASANA

         STANDARD OPERATING PROCEDURE 

GROUP A: MARMA CHIKITSA

Ø  POORVA KARMA

·         Patient will be asked to empty the bladder.

·         Patient will be asked to lie down comfortably for Marma stimulation.

·         Hands will be sanitized.

·         Patient’s privacy will be maintained during therapy.

Ø  PRADHAAN KARMA

·         Marma points will be located and stimulated one by one.

·         Marma point is touched either with the inter-phalangeal joint or side tip or pulp of thumb or fingers.

·          Pressure to be applied:  Â¼ Maathirai .

·         Each Marma point will be pressed for 15-18 times except Manibandha. (Manibandha – 8 times)

·         After giving pressure, the site will be rubbed gently to avoid the creation of a mark at the site.

Ø  PASCHAATKARMA

·         Patient should take rest for 1-2 minutes.

GROUP B: YOGA-PRANAYAMA

·         A special protocol of Yoga-Pranayama will be followed.

·         Patient will be instructed regarding Yoga-Pranayama to be done by herself.

·         It should be done in morning or evening hours, with empty stomach (at least having gap of 3-4 hours after meal) and in peaceful environment.

·         Clean, light colored and loose clothing should be done.

·         Proper and clean Yoga mat should be there.

·         Sitting in Padmasana (sitting with both legs crossed above each other and hands relaxing on the knees) and performing 3 times Omakara and then Anuloma-Viloma and Bhramari Pranayama, each Pranayama for 5 mins.

·         It should be followed by Suryanamaskar performed in a cyclic manner with proper inhalation and exhalation - each Asana should be held for 3 seconds.

·         3 sets should be performed with a break of 1 minute between each set.

·         The session should lastly end by Shavasana (lying down on a mat with eyes closed, keeping entire body relaxed) for 3 minutes.

        WITHDRAWL CRITERIA:

Who are not willing to continue the treatment.

 STASTICAL ANALYSIS

Collected data and observations will be analyzed critically and scientifically by employing statistical test and inference will be drawn on it.

 ETHICAL CLEARANCE

Ethical clearance will be obtained from the Institutional Ethical Committee.

This study will be registered in Clinical Trials Registry of India (CTRI)

Adverse reaction if any, will be reported.

DECLARATION:

Study will be completed in the stipulated time limit.

 
Close